Medtronic DDMC3D4 Implant Manual

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EVERA MRI™ S DR SURESCAN™ DDMC3D4

Digital dual-chamber implantable cardioverter defibrillator with SureScan™ Technology (DDE-DDDR)

MR Conditional with PhysioCurve™ Design, SmartShock™ Technology, Complete Capture Management® Diagnostic (ACM, RVCM)

Device Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.

Active Can, ATP During Charging, Capture Management, Cardiac Compass, CareAlert, CareLink, CareLink Express, ChargeSaver, Conexus, EnPulse, EnRhythm, EnTrust, Evera, Evera MRI, Export, Flashback, GEM, GEM DR, GEM III, InSync, InSync III Marquis, Integrity, Jewel, Kappa, Marker Channel, Marquis, Medtronic, Medtronic AT500, Medtronic CareAlert, Medtronic CareLink, MVP, PhysioCurve, PR Logic, Protecta, Quick Look, Reactive ATP, SmartShock, SureScan, T-Shock, TherapyGuide

1 System overview 4

1.1 Introduction 4

1.2 System description 4

1.3 Indications and usage 5

1.4 MRI conditions for use 5

1.5 Contraindications 6

1.6 Pre-implant consideration 6

1.7 Feature summary 7

2 Warnings, precautions, and potential adverse events 11

2.1 General warnings and precautions 11

2.2 Explant and disposal 11

2.3 Handling and storage instructions 12

2.4 Lead evaluation and lead connection 12

2.5 Device operation 13

2.6 Potential adverse events 14

3 Clinical data 16

3.1 Adverse events and clinical trial data 16

4 Implant procedure 18

4.1 Preparing for an implant 18

4.2 Selecting and implanting the leads 19

4.3 Testing the lead system 21

4.4 Connecting the leads to the device 22

4.5 Performing ventricular defibrillation threshold tests 24

4.6 Positioning and securing the device 26

4.7 Completing the implant procedure 27

4.8 Replacing a device 28

5 Product specifications 29

5.1 Physical characteristics 29

5.2 Replacement indicators 30

5.3 Projected service life 31

5.4 Energy levels and typical charge times 32

5.5 Magnet application 32

6 Device parameters 33

6.1 Emergency settings 33

6.2 Tachyarrhythmia detection parameters 33

6.3 Atrial tachyarrhythmia therapy parameters 35

6.4 Ventricular tachyarrhythmia therapy parameters 38

6.5 Pacing parameters 40

6.6 Medtronic CareAlert parameters 44

6.7 Data collection parameters 47

6.8 System test parameters 48

6.9 EP Study parameters 49

1 System overview

1.1 Introduction

This manual describes the Medtronic Model DDMC3D4 Evera MRI S DR SureScan dual-chamber, implantable cardioverter defibrillator (ICD). It contains model-specific feature information, indications and contraindications, warnings and precautions, instructions for implanting the device, quick reference specifications, and parameter tables.

The MRI SureScan feature permits a mode of operation that allows a patient with a SureScan system to be safely scanned by an MRI machine while the device continues to provide appropriate pacing. When programmed to On, MRI SureScan operation disables arrhythmia detection and all user-defined diagnostics. Before performing an MRI scan, refer to the MRI technical manual.

The following manuals and documents also contain information about the device:

MRI technical manual – This manual provides MRI-specific procedures and warnings and precautions.

Reference manual – This manual contains information about device features and describes how to use a

programmer to conduct a session. The reference manual applies to multiple models of ICD devices.

Explanation of symbols – This document defines the symbols that may appear on the device package. Refer to the package label to see which symbols apply specifically to this device.

Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals – This manual provides warnings, precautions, and guidance for health care professionals who perform medical therapies and diagnostic procedures on cardiac device patients. The manual also provides patient education information related to sources of electromagnetic interference (EMI) at home, at work, and in other environments.

Radio regulatory compliance insert – This document provides Federal Communications Commission (FCC) regulations and compliance information for the transmitter in this active implantable medical device.

1.2 System description

The Medtronic Model DDMC3D4 Evera MRI S DR SureScan dual-chamber, implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual-chamber, rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.

The device can detect ventricular tachyarrhythmias (VT/VF) automatically and can provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device can also detect atrial tachyarrhythmias (AT/AF) automatically and can provide treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.

The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.

Contents of sterile package – The package contains 1 implantable cardioverter defibrillator and 1 torque wrench.

Connectors – The device has a DF4 inline connector, which facilitates the connection of a DF4-LLHH right ventricular (RV) lead or a DF4-LLHO RV lead during implant. DF4-LLHH and DF4-LLHO refer to the international standard ISO 27186, which defines the lead connector contacts as low voltage (L), high voltage (H), and open (O).

Leads – The lead system used with this device must provide sensing, pacing, and cardioversion and defibrillation therapies to the right ventricle (RV) and sensing and pacing to the atrium (A). Do not use any lead with this device without first verifying lead and connector compatibility.

For information about selecting and implanting leads for this device, see Section 4.2, “Selecting and implanting the leads”, page 19.

Implantable device system – The Model DDMC3D4 Evera MRI S DR SureScan along with its pacing and defibrillation leads constitute the implantable portion of the device system.

Programmers and software – The Medtronic CareLink Programmer and software are used to program this device. Refer to the reference manual for information about using the programmer.

Programmers from other manufacturers are not compatible with Medtronic devices, but they do not damage Medtronic devices.

Medtronic patient activator – The activator allows you to turn on wireless telemetry for implanted devices that support wireless telemetry. The activator is used in conjunction with the Medtronic programmer with telemetry in the hospital or clinic.

Medtronic pacing system analyzer – A pacing system analyzer is used to measure the electrical characteristics of the implanted leads to assess their effectiveness for pacing and sensing.

Medtronic patient monitor – Patients use the Medtronic patient monitor to gather information automatically from their implanted devices and communicate the information to their physicians through the Medtronic CareLink Network. For information on using the patient monitor, refer to the patient manual; for connection and usage information, refer to the patient monitor literature.

CareLink Network – The Medtronic CareLink Network is an Internet-based service that allows a patient to transmit full cardiac device information from home or other locations to the physician over a secure server. The CareLink Network may be unavailable in some geographic locations.

CareLink Express monitor – The Medtronic A CareLink Express monitor is a portable interrogation and data transfer tool used with Medtronic implantable cardiac devices.

Medtronic patient assistant – Patients can use the Medtronic patient assistant to initiate recording of cardiac event data in the device memory, verify whether the implanted device has detected a suspected atrial tachyarrhythmia, and, if the device is programmed to allow patient-activated cardioversion, request delivery of atrial cardioversion therapy.

1.3 Indications and usage

The Evera MRI S DR SureScan system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

Notes:

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The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias.

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The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device-classified atrial tachycardia (AT) was found to be 17% and in terminating device-classified atrial fibrillation (AF) was found to be 16.8% in the VT/AT patient population studied.

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The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device-classified atrial tachycardia (AT) was found to be 11.7% and in terminating device-classified atrial fibrillation (AF) was found to be 18.2% in the AF-only patient population studied.

1.4 MRI conditions for use

A complete SureScan defibrillation system is required for use in the MR environment. A complete SureScan defibrillation system includes an Evera MRI S DR SureScan device with a SureScan right atrial pacing lead and a SureScan defibrillation lead. To verify that components are part of a SureScan system, visit

http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.

Warning: Do not scan a patient without first programming MRI SureScan to On. Scanning the patient without programming MRI SureScan to On may result in patient harm or damage to the SureScan defibrillation system.

Note: MRI SureScan cannot be programmed to On if the device is recommended for replacement.

Patients and their implanted systems must be screened to meet the following requirements:

Cardiology requirements

Patients and their implanted systems must be screened to meet the following requirements:

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The patient has no implanted lead extenders, lead adaptors, or abandoned leads.

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The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance history.

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The SureScan defibrillation system is implanted in the left or right pectoral region.

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The SureScan device is operating within the projected service life.

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For patients whose device will be programmed to an asynchronous pacing mode when the MRI SureScan mode is programmed to On, no diaphragmatic stimulation is present when the paced leads have a pacing output of 5.0 V and a pulse width of 1.0 ms.

Caution: It is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms for pacemaker-dependent patients. A higher pacing capture threshold may indicate an issue with the implanted lead.

Note: For radiology requirements for an MRI scan, refer to the MRI technical manual.

Patient monitoring and rescue requirements:

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Continuous patient monitoring is required while MRI SureScan is programmed to On.

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In the event that patient rescue is required, an external defibrillator must be immediately available.

Training requirements

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A health professional who has completed cardiology SureScan training must be present during the programming of the MRI SureScan feature.

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A health professional who has completed radiology SureScan training must be present during the MRI scan.

1.5 Contraindications

The Evera MRI S DR SureScan system is contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis.

The device is contraindicated for patients who have a unipolar pacemaker implanted.

The device is contraindicated for patients with incessant VT or VF.

The device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.

1.6 Pre-implant consideration

Patient evaluation for the implant of Evera MRI S DR SureScan Model DDMC3D4 should include the following consideration about a concomitant implant with a neurostimulator:

Concomitant neurostimulator and cardiac device implants – Some patients have medical conditions that require the implant of both a neurostimulator and a cardiac device (for example, a pacemaker, a defibrillator, or a monitor). In this case, physicians (for example, a neurologist, a neurosurgeon, a cardiologist, and a cardiac surgeon) involved with either device should contact Medtronic Technical Services or their Medtronic representative before implanting the patient with the second device. Based on the particular devices that the

physicians have prescribed, Medtronic can provide the necessary precautions and warnings related to the implant procedure. For information about how to contact Medtronic, see the telephone numbers and addresses provided on the back cover of this manual.

1.7 Feature summary

The following features are available in this device. For a list of the features that are enabled at shipping, see the “Shipped” column of the tables in Chapter 6, “Device parameters”, page 33.

1.7.1 Programmer software features

For more information about these features, see the reference manual.

Conexus wireless telemetry – This feature enables wireless transmission of data between an implanted device and the programmer in the hospital or clinic and between an implanted device and a home monitor in the patient’s home.

Emergency therapies – During a patient session, defibrillation, cardioversion, fixed burst pacing, and emergency VVI can be initiated manually to treat ventricular tachyarrhythmia episodes quickly.

Live Rhythm Monitor – This window on the programmer displays ECG, Leadless ECG (LECG), Marker Channel with marker annotations, and telemetered EGM waveform traces. It also displays the patient heart rate and interval in the upper left-hand corner of the window.

Checklist – This feature presents an interactive list of common tasks that are performed during an implant session or a follow-up session. When a clinician selects a task, the associated programmer screen for that task appears. Clinicians can set up their own checklists or use a Medtronic standard checklist supplied with the programmer.

Leadless ECG – This device feature allows clinicians to view and record a signal equivalent to an ECG without attaching surface ECG leads.

TherapyGuide – This feature suggests a set of parameters based on the programmed information about the patient’s clinical conditions. TherapyGuide does not replace a physician’s expert judgment. The physician can accept, reject, or modify any of the suggested parameter values.

Patient Information – This feature allows clinicians to store patient-related information on the programmer that they can view and print during a patient session.

1.7.2 Diagnostic data features

When MRI SureScan is programmed to On, diagnostic data is not collected. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions.

For more information about these features, see the reference manual.

Quick Look II – This screen on the programmer presents overview data about device operation and patient rhythms collected since the last patient session. It includes links to more detailed status and diagnostic information stored in the device, such as arrhythmia episodes and therapies provided.

Medtronic CareAlert – If the device identifies any CareAlert programmed or automatic alert conditions, this feature sends a wireless alert signal to the patient monitor, transmits an alert notification to the clinic, and sounds a patient alert tone to notify the patient to seek medical attention.

RV Lead Integrity Alert – This feature sounds an alert tone to warn the patient that a potential RV lead problem is suspected, which could indicate a lead fracture. When the alert criteria are met, device settings are automatically adjusted to avoid the delivery of inappropriate therapy.

Cardiac Compass Trends – This feature presents an overview of the patient’s condition over the past 14 months with graphs that display long-term clinical trends in heart rhythm and device status, such as frequency of arrhythmias, heart rates, and device therapies.

Arrhythmia episode data – The system compiles an arrhythmia episode log that the clinician can use to view summary and detailed diagnostic data quickly, including stored EGM, for the selected arrhythmia episode. Also

available on the programmer are episode and therapy counters, stored data showing the number of times that arrhythmias and therapies have occurred.

Flashback Memory – This diagnostic feature records the intervals that immediately preceded tachyarrhythmia episodes or that preceded the last interrogation of the device and plots the interval data over time.

Rate Drop Response episodes data – This feature displays beat-to-beat data that is useful in analyzing Rate Drop Response episodes and the events leading up to these episodes. The feature records data about episodes that meet the programmed rate drop detection criteria.

Rate Histograms – This diagnostic feature shows range distributions for the patient’s heart rate.

1.7.3 Pacing features

For more information about these features, see the reference manual.

Rate Response – This feature adjusts the cardiac pacing rate in response to changes in sensed patient activity.

Rate Profile Optimization – This feature monitors the patient’s daily and monthly sensor rate profiles and adjusts

the rate response curves over time to achieve a prescribed target rate profile. The goal is to ensure that the rate response remains appropriate for the full range of patient activities.

Capture Management – This feature monitors pacing thresholds with daily pacing threshold searches and, if programmed to do so, adjusts the pacing amplitudes toward a target amplitude.

Rate Adaptive AV – This dual-chamber pacing feature varies the paced AV intervals and the sensed AV intervals as the heart rate increases or decreases to maintain 1:1 tracking and AV synchrony.

Auto PVARP – This feature adjusts the post-ventricular atrial refractory period (PVARP) in response to changes in the patient’s heart rate or pacing rate. PVARP is longer at lower tracking rates to prevent pacemaker-mediated tachycardia and shorter at higher rates to maintain 1:1 tracking.

Rate Drop Response – This feature monitors the heart for a significant drop in rate and responds by pacing the heart at an elevated rate for a programmed duration.

Sleep – This feature causes the device to pace at a slower rate during a programmed sleep period.

Non-Competitive Atrial Pacing (NCAP) – This feature prohibits atrial pacing within a programmable interval

after a refractory atrial event.

PMT (pacemaker-mediated tachycardia) Intervention – This feature automatically detects and interrupts device-defined pacemaker-mediated tachycardias.

PVC Response – This feature extends PVARP following a premature ventricular contraction (PVC) to avoid tracking a retrograde P-wave and to prevent retrograde conduction from inhibiting an atrial pace.

Ventricular Safety Pacing (VSP) – This feature prevents inappropriate inhibition of ventricular pacing caused by crosstalk or ventricular oversensing.

Mode Switch – This feature switches the device pacing mode from a dual-chamber atrial tracking mode to a nontracking mode during an atrial tachyarrhythmia. This feature prevents rapid ventricular pacing that can result from tracking a high atrial rate and restores the programmed pacing mode when the atrial tachyarrhythmia ends.

Conducted AF Response – This feature helps to promote a regular ventricular rate during conducted AT/AF episodes by increasing the pacing rate in concert with the patient’s intrinsic ventricular response.

Atrial Rate Stabilization (ARS) – This feature adapts the atrial pacing rate in response to a PAC (premature atrial contraction) to avoid long sinus pauses following short atrial intervals.

Atrial Preference Pacing (APP) – This feature maintains a consistent activation sequence by providing continuous pacing that is closely matched to the intrinsic rate.

Post Mode Switch Overdrive Pacing (PMOP) – This feature works with the Mode Switch feature to deliver overdrive atrial pacing during the vulnerable phase following the termination of an AT/AF episode.

Post VT/VF Shock Pacing – This feature provides temporary overdrive pacing for a programmed duration after a ventricular high-voltage therapy.

Ventricular Rate Stabilization (VRS) – This feature adjusts the pacing rate dynamically to eliminate the long pause that typically follows a premature ventricular contraction (PVC).

1.7.4 Tachyarrhythmia detection features

When MRI SureScan is programmed to On, tachyarrhythmia detection and therapies are suspended. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions.

For more information about these features, see the reference manual.

AT/AF detection – This feature analyzes the atrial rate and its effect on the ventricular rhythm to determine whether the patient is currently experiencing an atrial tachyarrhythmia. Evidence of an atrial tachyarrhythmia is based on the number and timing of atrial events during ventricular intervals. Depending on programming, the device delivers a programmed sequence of atrial therapies or continues monitoring without delivering therapy.

VT/VF detection – This feature uses programmable detection zones to classify ventricular events. If the number of tachyarrhythmia events in a zone exceeds a programmed threshold, the device detects a ventricular tachyarrhythmia episode. Depending on programming, the device delivers a scheduled therapy, re-evaluates the patient’s heart rhythm, and terminates or redetects the episode.

PR Logic – This set of features uses pattern and rate analysis to discriminate between supraventricular tachycardias (SVTs) and true ventricular tachyarrhythmias and to withhold inappropriate VT/VF detection and therapy during episodes of rapidly conducted SVT.

Wavelet – This feature is designed to prevent the detection of rapidly conducted SVTs as ventricular tachyarrhythmias by comparing the shape of each QRS complex during a fast ventricular rate to a template. The feature offers the option to collect and maintain the stored template automatically.

Onset – This feature helps prevent the detection of sinus tachycardia as VT by evaluating the acceleration of the ventricular rate.

Stability – This feature helps to prevent the detection of atrial fibrillation as ventricular tachyarrhythmia by evaluating the stability of the ventricular rate. If the device determines that the ventricular rate is not stable, it withholds VT detection.

High Rate Timeout – This feature allows the device to deliver therapy for any ventricular tachyarrhythmia that continues beyond the programmed length of time.

TWave Discrimination – This feature withholds VT/VF detection when a fast ventricular rate is detected because of oversensed T-waves, avoiding the delivery of an inappropriate therapy.

RV Lead Noise Discrimination – When the device identifies lead noise due to a suspected lead problem, this feature withholds VT/VF detection to prevent the delivery of an inappropriate therapy. Also, if programmed, an alert tone sounds to notify the patient to seek medical attention.

1.7.5 Tachyarrhythmia therapy features

For more information about these features, see the reference manual.

Atrial therapy scheduling – This feature enables the clinician to program the delivery of automatic atrial therapies. Each time that an AT/AF therapy is needed, the device schedules one of the available therapies based on clinician programming. The Reactive ATP option allows the device to repeat programmed atrial antitachycardia pacing (ATP) therapies during long AT/AF episodes. Therapies are repeated after a programmed interval or when the atrial rhythm changes in regularity or cycle length.

Atrial antitachycardia pacing (ATP) – These therapies respond to an AT/AF episode or a Fast AT/AF episode with rapid sequences of pacing pulses to terminate detected atrial tachyarrhythmias. The device uses 3 programmable therapies, Burst+, Ramp, and 50 Hz Burst, to treat an episode.

Atrial cardioversion – This therapy delivers a high-voltage shock to treat an AT/AF episode or a Fast AT/AF episode. Atrial cardioversion delivery is synchronized to a sensed ventricular event and cannot exceed a programmable daily limit within programmable times. The patient also can request atrial cardioversion using an external Patient Assistant. Patient-activated atrial cardioversion is delivered only if an AT/AF episode is detected at the time of the request.

Programmable Active Can and SVC electrodes – The device provides the capability to disable either the Active Can or the SVC electrode as part of the high-voltage therapy delivery pathway.

Ventricular fibrillation (VF) therapies – Automatic defibrillation shocks are available to treat VF episodes. The first defibrillation therapy requires VF confirmation before delivery. After the first shock has been delivered, shocks are delivered asynchronously if synchronization fails. The ATP During Charging feature allows the device to deliver a sequence of ventricular antitachycardia pacing therapy while the device charges its capacitors for the first defibrillation therapy. The device can also be programmed to attempt an additional sequence of ATP therapy before charging starts.

Ventricular antitachycardia pacing (ATP) – These therapies respond to a VT episode or an FVT episode with rapid sequences of pacing pulses to terminate detected ventricular tachyarrhythmias. Therapy options include Burst, Ramp, and Ramp+, each with a programmable number of sequences.

Ventricular cardioversion – This therapy delivers a high-voltage shock to treat a VT episode or an FVT episode. Therapy is synchronized to a sensed ventricular event.

Progressive Episodes Therapies – This feature causes the device to skip therapies or modify high-voltage energy levels to ensure that each therapy delivered during an episode is at least as aggressive as the previous therapy.

1.7.6 Testing features

For more information about these features, see the reference manual.

Underlying Rhythm Test – This feature temporarily inhibits the pacing output of the device to enable the clinician to evaluate the patient’s intrinsic heart rhythm. During the test, the device is temporarily programmed to a nonpacing mode.

Pacing Threshold test – This feature allows the clinician to determine the patient’s pacing stimulation thresholds. This information can be used to determine appropriate amplitude and pulse width settings that ensure capture and minimize output.

Wavelet Test – This feature evaluates the accuracy of the current wavelet template and allows the clinician to collect a new template, if necessary.

Lead Impedance Test – This feature tests the integrity of the implanted lead system by measuring the impedance of the pacing and high-voltage electrodes. The test uses low-voltage, subthreshold pulses to make these measurements.

Sensing Test – This feature measures P-wave and R-wave amplitudes to help the clinician assess lead integrity and sensing performance. Mode, AV Delay, and Lower Rate can be programmed temporarily so that the device is not pacing the patient’s heart, increasing the likelihood that sensed events will occur.

Charge/Dump Test – This feature tests the charge time of the capacitors and dumps any charge remaining on the capacitors.

EP Studies – This set of protocols allows clinicians to induce arrhythmias during electrophysiology studies. The available induction protocols are T-Shock, 50 Hz Burst, Fixed Burst, and Programmed Electrical Stimulation. Manual therapies are also available.

1.7.7 Additional operations

MRI SureScan – This feature allows patients to be scanned safely by an MRI machine when used according to

the specified MRI conditions for use. Refer to the MRI technical manual for additional information.

2 Warnings, precautions, and potential adverse events

2.1 General warnings and precautions

A complete SureScan defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and precautions.

A complete dual-chamber SureScan defibrillation system includes an Evera MRI S DR SureScan ICD with a SureScan right atrial pacing lead and a SureScan defibrillation lead.

Refer to the Medical Procedure and EMI Precautions manual for information about hazards related to medical therapies and diagnostic procedures on patients with cardiac devices. This manual also includes information about sources of EMI in the patient’s environment.

Anti-coagulation – Use of the device should not change the application of established anti-coagulation protocols.

Avoiding shock during handling – Disable tachyarrhythmia detection during implant, explant, or postmortem

procedures. The device can deliver a high-voltage shock if the defibrillation terminals are touched.

Electrical isolation during implant – Do not allow the patient to have contact with grounded electrical equipment that might produce electrical current leakage during implant. Electrical current leakage may induce tachyarrhythmias that may result in the patient’s death.

External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever tachyarrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant testing.

Note: An external defibrillator must be immediately available while the MRI SureScan mode is programmed to On.

Lead compatibility – Do not use another manufacturer’s leads without demonstrated compatibility with

Medtronic devices. If a lead is not compatible with a Medtronic device, the result may be undersensing of cardiac activity, failure to deliver necessary therapy, or a leaking or intermittent electrical connection.

Occurrence of stroke – Following an ischemic or cerebrovascular accident, disable atrial cardioversion therapies until the patient has stabilized.

2.2 Explant and disposal

Consider the following information related to device explant and disposal:

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To prevent the device from delivering unwanted shocks, interrogate the device and disable tachyarrhythmia detection before explanting, cleaning, or shipping the device.

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Explant the implanted device postmortem. In some countries, explanting battery-operated implanted devices is mandatory because of environmental concerns; check the local regulations. In addition, the device may explode if subjected to incineration or cremation temperatures.

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Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted devices.

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Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal regulations.

2.3 Handling and storage instructions

Carefully observe these guidelines when handling or storing the device.

2.3.1 Device handling

Checking and opening the package – Before opening the sterile package tray, visually check for any signs of

damage that might invalidate the sterility of the package contents.

If the package is damaged – The device packaging consists of an outer tray and an inner tray. Do not use the device or accessories if the outer packaging tray is wet, punctured, opened, or damaged. Return the device to Medtronic because the integrity of the sterile packaging or the device functionality may be compromised. This device is not intended to be resterilized.

Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This product is for single use only and is not intended to be resterilized.

Device temperature – Allow the device to reach room temperature before it is programmed or implanted. Device temperature above or below room temperature may affect initial device function.

Dropped device – Do not implant the device if it is dropped on a hard surface from a height of 30 cm (12 in) or more after it is removed from its packaging.

Fluid immersion – Do not immerse the device in fluid or flush the connector ports at the time of implant. Doing so could adversely affect the performance of the device and lead system.

“Use by” date – Do not implant the device after the “Use by” date because the battery longevity could be reduced.

Single use – This product is intended for single use only. Do not resterilize and re-implant the explanted product.

2.3.2 Device storage

Avoid magnets – To avoid damaging the device, store the device in a clean area away from magnets, kits

containing magnets, and any sources of electromagnetic interference.

Storage temperature – Store and transport the package between –18°C and +55°C (0°F and 131°F). Device reset may occur at temperatures below –18°C (0°F). Device longevity may decrease and performance may be affected at temperatures above +55°C (131°F).

2.4 Lead evaluation and lead connection

Refer to the lead technical manuals for specific instructions and precautions about lead handling.

Torque wrench – Use only the torque wrench supplied with the device. The torque wrench is designed to prevent damage to the device from overtightening a setscrew. Other torque wrenches (for example, a blue-handled or right-angled torque wrench) have torque capabilities greater than the lead connector can tolerate.

Lead connection – Consider the following when connecting the lead to the device:

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Cap abandoned leads to avoid transmitting electrical signals.

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Plug any unused lead ports to protect the device.

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Verify lead connections. Loose lead connections may result in inappropriate sensing and failure to deliver arrhythmia therapy.

Lead impedance – Consider the following information about lead impedance when evaluating the lead system:

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Ensure that the defibrillation lead impedance is greater than 20 Ω. An impedance of less than 20 Ω may damage the device or prevent the delivery of high-voltage therapy.

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Before taking electrical or defibrillation efficacy measurements, move objects made from conductive materials, such as guide wires, away from all electrodes. Metal objects, such as guide wires, can short circuit a device and a lead, causing electrical current to bypass the heart and possibly damage the device and the lead.

2.5 Device operation

Warning: Leads other than SureScan leads may be used with the DDMC3D4 device, but if leads other than

SureScan leads are used, the system is contraindicated for MRI scans. Before performing an MRI scan, refer to the MRI technical manual for additional information.

Accessories – Use this device only with accessories, parts subject to wear, and disposable items that have been tested to technical standards and found safe by an approved testing agency.

Atrial Capture Management – Atrial Capture Management feature does not adjust atrial outputs to values greater than 5.0 V or 1.0 ms. If the patient needs atrial pacing output greater than 5.0 V or 1.0 ms, manually program the atrial amplitude and the pulse width. If a lead dislodges partially or completely, Atrial Capture Management feature may not prevent loss of capture.

Battery depletion – Carefully monitor device longevity by checking battery voltage and replacement indicators. Battery depletion eventually causes the device to stop functioning. Cardioversion and defibrillation are high-energy therapies that shorten device longevity. An excessive number of charging cycles also shortens device longevity.

Charge Circuit Timeout or Charge Circuit Inactive message – Contact a Medtronic representative and replace the device immediately if the programmer displays a Charge Circuit Timeout or Charge Circuit Inactive message. If this message is displayed, high-voltage therapies are not available for the patient.

Concurrent pacemaker use – If a separate pacemaker is used concurrently with the device, verify that the device does not sense the output pulses of the pacemaker. Sensing the output pulses of the pacemaker can affect the detection of tachyarrhythmias. Program the pacemaker to deliver pacing pulses at intervals longer than the tachyarrhythmia detection intervals.

Device status indicators – If any of the device status indicators (for example, Electrical Reset) are displayed on the programmer after interrogating the device, inform a Medtronic representative immediately. If these device status indicators are displayed, therapies may not be available to the patient.

Electrical reset – Electrical reset can be caused by exposure to temperatures below –18°C (0°F) or strong electromagnetic fields. Advise patients to avoid strong electromagnetic fields. Observe temperature storage limits to avoid exposure of the device to cold temperatures. If a partial reset occurs, pacing resumes in the programmed mode with many of the programmed settings retained. If a full reset occurs, the device operates in VVI mode at 65 bpm. Electrical reset is indicated by a programmer warning message that is displayed immediately upon interrogation. To restore the device to its previous operation, it must be reprogrammed. Inform a Medtronic representative if your patient’s device has reset.

End of Service (EOS) indicator – Replace the device immediately if the programmer displays an EOS indicator. The device may soon lose the ability to pace, sense, and deliver therapy adequately.

Follow-up testing – Consider the following information when performing follow-up testing of the device:

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Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or induced tachyarrhythmias may occur during device testing.

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Changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT), preventing the device from terminating the patient’s tachyarrhythmias postoperatively. Successful termination of ventricular fibrillation or ventricular tachycardia during the implant procedure is no assurance that tachyarrhythmias can be terminated postoperatively.

Higher than programmed energy – The device may deliver a therapy of higher than programmed energy if it was previously charged to a higher energy and that charge remains on the capacitors.

Magnets – Positioning a magnet over the device suspends tachyarrhythmia detection but does not alter bradycardia therapy. If you place a programming head over the device during a wireless telemetry session, the magnet in the programming head always suspends tachyarrhythmia detection. If you place a programming head over the device and establish a nonwireless telemetry session, tachyarrhythmia detection is not suspended.

PMT (pacemaker-mediated tachycardia) Intervention – Even with the PMT Intervention feature programmed to On, PMTs may still require clinical intervention, such as device reprogramming, drug therapy, or lead evaluation.

Pacing and sensing safety margins – Lead maturation (at least one month after implant) may cause sensing amplitudes to decrease and pacing thresholds to increase, which can cause undersensing or a loss of capture. Provide an adequate safety margin when selecting values for pacing amplitude, pacing pulse width, and sensitivity parameters.

Patient safety during a wireless telemetry session – Make sure that you have selected the appropriate patient before proceeding with a wireless patient session. Maintain visual contact with the patient for the duration of the session. If you select the wrong patient and continue with the session, you may inadvertently program the patient’s device to the wrong settings.

Programmers – Use only Medtronic programmers and application software to communicate with the device. Programmers and software from other manufacturers are not compatible with Medtronic devices.

Rate control – Decisions regarding rate control should not be based on the ability of the device to prevent atrial arrhythmias.

Rate-responsive modes – Do not program rate-responsive modes for patients who cannot tolerate rates above the programmed Lower Rate. Rate-responsive modes may cause discomfort for those patients.

RV Capture Management – The RV Capture Management feature does not program right ventricular outputs to values greater than 5.0 V or 1.0 ms. If the patient needs right ventricular pacing output greater than 5.0 V or 1.0 ms, manually program right ventricular amplitude and pulse width. If a lead dislodges partially or completely, the RV Capture Management feature may not prevent loss of capture.

Shipping values – Do not use shipping values or nominal values for pacing amplitude and sensitivity without verifying that the values provide adequate safety margins for the patient.

Single chamber atrial modes – Do not program single chamber atrial modes for patients with impaired AV nodal conduction. Ventricular pacing does not occur in these modes.

Slow retrograde conduction and PMT – Slow retrograde conduction may induce pacemaker-mediated tachycardia (PMT) when the VA conduction time is greater than 400 ms. Programming PMT Intervention can help prevent PMT only when the VA conduction time is less than 400 ms.

Testing for cross-stimulation – At implant, and regularly when atrial ATP therapy is enabled, conduct testing at the programmed atrial ATP output settings to ensure that ventricular capture does not occur. This testing is particularly important when the lead is placed in the inferior atrium.

Twiddler’s syndrome – Twiddler’s syndrome, the tendency of some patients to manipulate their device after implant, may cause the pacing rate to increase temporarily if the device is programmed to a rate-responsive mode.

2.5.1 Pacemaker-dependent patients

Ventricular Safety Pacing – Always program Ventricular Safety Pacing (VSP) to On for pacemaker-dependent

patients. Ventricular Safety Pacing prevents ventricular asystole due to inappropriate inhibition of ventricular pacing caused by oversensing in the ventricle.

ODO pacing mode – Pacing is disabled under ODO pacing mode. Do not program the ODO mode for pacemaker-dependent patients. Instead, use the Underlying Rhythm Test to provide a brief period without pacing support.

Underlying Rhythm Test – Use caution when using the Underlying Rhythm Test to inhibit pacing. The patient is without pacing support when pacing is inhibited.

2.6 Potential adverse events

The following are known potential adverse events associated with the use of pacing systems:

●

Acceleration of tachyarrhythmias (caused by device)

●

Air embolism

●

Bleeding

●

Body rejection phenomena, including local tissue reaction

●

Cardiac dissection

●

Cardiac perforation

●

Cardiac tamponade

●

Chronic nerve damage

●

Constrictive pericarditis

●

Death

●

Device migration

●

Endocarditis

●

Erosion

●

Excessive fibrotic tissue growth

●

Extrusion

●

Fibrillation or other arrhythmias

●

Fluid accumulation

●

Formation of hematomas/seromas or cysts

●

Heart block

●

Heart wall or vein wall rupture

●

Hemothorax

●

Infection

●

Keloid formation

●

Lead abrasion and discontinuity

●

Lead migration/dislodgement

●

Mortality due to inability to deliver therapy

●

Muscle and/or nerve stimulation

●

Myocardial damage

●

Myocardial irritability

●

Myopotential sensing

●

Pericardial effusion

●

Pericardial rub

●

Pneumothorax

●

Poor connection of the lead to the device, which may lead to oversensing, undersensing, or a loss of therapy

●

Threshold elevation

●

Thrombotic embolism

●

Thrombosis

●

Tissue damage

●

Tissue necrosis

●

Valve damage (particularly in fragile hearts)

●

Venous occlusion

●

Venous perforation

Additional known potential adverse events associated with the use of ICD systems include the following events:

●

Inappropriate shocks

●

Potential mortality due to inability to defibrillate

●

Shunting current or insulating myocardium during defibrillation

Patients susceptible to frequent shocks despite medical management could develop psychological intolerance to an ICD system that might include the following conditions:

●

Dependency

●

Depression

●

Fear of premature battery depletion

●

Fear of shocking while conscious

●

Fear that shocking capability may be lost

●

Imagined shocking (phantom shock)

3 Clinical data

3.1 Adverse events and clinical trial data

Information regarding clinical studies and adverse events related to this device is available at www.medtronic.com/manuals.

The following clinical studies are related to this device:

Atrial Capture Management (ACM) study – This clinical study, which evaluated the Atrial Capture Management feature in EnPulse pacemakers, provides support for the Atrial Capture Management feature in Evera MRI S DR SureScan Model DDMC3D4 devices.

Atrial Fibrillation Symptoms Mediated by Pacing to Mean Rates (AF SYMPTOMS) – This study evaluated the long-term effects of Conducted AF Response in patients with atrial fibrillation and intact atrioventricular (AV) conduction. It provides support for the Conducted AF Response feature in Evera MRI S DR SureScan Model DDMC3D4 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called Conducted AF Response in the Evera MRI S DR SureScan Model DDMC3D4 devices.

Atrial Septal Pacing Efficacy Trial (ASPECT) – This clinical study, which evaluated the safety and efficacy of the Medtronic AT500 DDDRP Pacing System devices, provides support for the atrial intervention pacing therapies.

Atrial Therapy Efficacy and Safety Trial (ATTEST) – This clinical study, which evaluated the safety and efficacy of the Medtronic AT500 DDDRP Pacing System devices, provides support for the Evera MRI S DR SureScan Model DDMC3D4 devices.

The Enhanced Surveillance of Right Ventricle Lead Integrity Alert (RV LIA) – This study, which prospectively assessed the performance of the Right Ventricle Lead Integrity Alert, provided an estimate of the probability of receiving a three-day warning for patients with a lead fracture. The study provides support for the RV Lead Integrity Alert feature in Evera MRI S DR SureScan Model DDMC3D4 devices.

EnRhythm clinical study – This clinical study, which evaluated the safety and efficacy of the EnRhythm Model P1501DR devices, provides support for MVP mode pacing and the Reactive ATP feature in the Evera MRI S DR SureScan Model DDMC3D4 devices.

EnTrust clinical study – This clinical study, which evaluated the safety and clinical performance of the EnTrust ICD system, provides support for the Evera MRI S DR SureScan Model DDMC3D4 devices.

EnTrust tachyarrhythmia detection performance vs. GEM DR tachyarrhythmia detection performance –

This retrospective evaluation of the EnTrust detection algorithm was performed on spontaneous rhythms recorded in patients implanted with the GEM DR ICD. It provided support for the modifications made to the PR Logic Sinus Tachycardia criterion in the EnTrust devices. These modifications also apply to the Evera MRI S DR SureScan Model DDMC3D4 devices.

Evera MRI System study – This clinical study was executed to confirm safety and efficacy of the Evera MRI system in the clinical MRI environment when subjects receive MRI scans up to 2 W/kg SAR without positioning restrictions (MRI scans may occur anywhere on the body), providing support for the Evera MRI S DR SureScan Model DDMC3D4 device.

GEM DR clinical study – This clinical study, which evaluated the appropriateness of dual-chamber sensing and tachyarrhythmia detection during induced and simulated cardiac arrhythmias in GEM DR devices, provides support for the Evera MRI S DR SureScan Model DDMC3D4 devices.

GEM III DR Model 7275 MVP study – This clinical study, which evaluated the performance of MVP mode pacing in the GEM III DR Model 7275 devices, provides support for MVP mode in the Evera MRI S DR SureScan Model DDMC3D4 devices.

InSync III Marquis clinical study – This clinical study, which evaluated the Conducted AF Response feature in the InSync III Marquis devices, provides support for Conducted AF Response in Evera MRI S DR SureScan Model DDMC3D4 devices.

Jewel AF clinical study for AF patients only – This clinical study evaluated the atrial tachyarrhythmia therapies and dual-chamber tachyarrhythmia detection algorithm provided by Jewel AF Model 7250 devices. The patients included in the study had a primary indication of atrial fibrillation or atrial flutter. It provides support for atrial tachyarrhythmia therapies and dual-chamber tachyarrhythmia detection in the Evera MRI S DR SureScan Model DDMC3D4 devices.

Jewel AF clinical study for VT/AT patients – This clinical study evaluated the atrial tachyarrhythmia therapies and dual-chamber tachyarrhythmia detection algorithm provided by Jewel AF Model 7250 devices. The patients included in the study had a primary indication of ventricular tachyarrhythmia. Some of the patients in the study also had a history of atrial tachyarrhythmia. This clinical study provides support for atrial tachyarrhythmia therapies and dual-chamber tachyarrhythmia detection in the Evera MRI S DR SureScan Model DDMC3D4 devices.

Kappa 700 clinical study – This study, which evaluated the safety and clinical performance of the Kappa 700 pacemakers, provides support for the Right Ventricular Capture Management feature and other bradycardia pacing features.

Marquis MVP download study – This clinical study, which evaluated the performance of MVP mode pacing in the Marquis DR Model 7274 devices, provides support for MVP mode in the Evera MRI S DR SureScan Model DDMC3D4 devices.

Marquis VR Single Chamber ICD study – This clinical study, which evaluated the operation of the Wavelet Auto-Template Algorithm in the Model 7230 Marquis VR devices, provides support for the Wavelet detection feature in Evera MRI S DR SureScan Model DDMC3D4 devices.

PR Logic with Wavelet performance – This retrospective evaluation was conducted to demonstrate the safety and performance of the combined PR Logic and Wavelet SVT discrimination features by assessing the impact to VT/VF detection sensitivity and specificity of turning Wavelet on in dual-chamber ICD and CRT-D devices. This evaluation provides support for the PR Logic and Wavelet features in Evera MRI S DR SureScan Model DDMC3D4 devices.

Protecta detection performance – This retrospective evaluation was performed using human rhythms collected from various clinical trials and provides support that the addition of multiple therapy discriminators in the Protecta products does not affect the overall detection performance of the Evera MRI S DR SureScan Model DDMC3D4 devices.

Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT) – This clinical study evaluated the efficacy of the intervention pacing therapies on symptomatic AT/AF episodes in subjects where the lead was placed in the Bachmann’s Bundle region. The results of the study failed to demonstrate effectiveness of the intervention pacing therapies. Evaluation of the RESPECT study data indicated that the intervention pacing features did not significantly reduce the rate of symptomatic AT/AF episodes and these results did not confirm the findings from previous trials. The pre-specified subgroups were tested for therapeutic effect, but none had results suggesting benefit. When intervention pacing algorithms were programmed ON, atrial pacing percentage increased by 18.1% (P<0.001) with a modest, yet statistically significant, increase in mean heart rate of 2.4 beats per minute (P<0.001).

RV Lead Integrity Alert performance retrospective evaluation – This retrospective evaluation assessed the ability of the RV Lead Integrity Alert feature to provide advance notice of a Sprint Fidelis lead fracture. The evaluation provides support for the RV Lead Integrity Alert feature in Evera MRI S DR SureScan Model DDMC3D4 devices.

RV Lead Noise Discrimination VF detection performance – This retrospective evaluation was conducted using spontaneous rhythms and provides support that the RV Lead Noise Discrimination algorithm does not impact time to detection in Evera MRI S DR SureScan Model DDMC3D4 devices.

Template Matching Morphology (TEMM) study – This clinical study, which evaluated the functionality of the Template Matching Morphology (TEMM) algorithm, provides support for the Wavelet detection feature in Evera MRI S DR SureScan Model DDMC3D4 devices.

TWave Discrimination VF detection performance – This retrospective evaluation was conducted using induced rhythms and provides support that the TWave Discrimination algorithm does not impact time to detection in Evera MRI S DR SureScan Model DDMC3D4 devices.

4 Implant procedure

4.1 Preparing for an implant

To retain the ability to scan the SureScan defibrillation system safely during MRI scans, the MRI conditions for use in Section 1.4 must be followed. Refer to the MRI technical manual for additional information.

The following implant procedures are provided for reference only. Proper surgical procedures and sterile techniques are the responsibility of the physician. Each physician must apply the information in these procedures according to professional medical training and experience.

For information about replacing a previously implanted device, see Section 4.8, “Replacing a device”, page 28.

Ensure that you have all of the necessary instruments, system components, and sterile accessories to perform the implant.

4.1.1 Instruments, components, and accessories required for an implant

The following non-implanted instruments are used to support the implant procedure:

●

Medtronic programmer

●

Programmer software application for the Evera MRI S DR SureScan Model DDMC3D4 device

●

Medtronic pacing system analyzer

●

External defibrillator

The following sterile system components and accessories are used to perform the implant:

●

Implantable device and lead system components

●

Programming head sleeve (if a programming head is used) Note: If a sterilized programming head is used during an implant, a sterile programming head sleeve is not necessary.

●

Pacing system analyzer cables

●

Lead introducers appropriate for the lead system

●

Extra stylets of appropriate length and shape

4.1.2 Setting up the programmer and starting the application

See the reference manual for the Medtronic programmer for instructions about how to set up the programmer. The Model SW033 software must be installed on the programmer. Establish telemetry with the device and start a patient session.

4.1.3 Considerations for preparing for an implant

Review the following information before implanting the leads or device:

Warning: Leads other than SureScan leads may be used with the DDMC3D4 device, but if leads other than SureScan leads are used, the system is contraindicated for MRI scans. Before performing an MRI scan, refer to the MRI technical manual for additional information.

Your Medtronic representative can install the Model SW033 software application.

Warning: Do not allow the patient to have contact with grounded electrical equipment that might produce electrical current leakage during implant. Electrical current leakage may induce tachyarrhythmias that may result in the patient’s death.

Warning: Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or induced tachyarrhythmias may occur during device testing, implant procedures, and post-implant testing.

Caution: The device is intended for implant in the pectoral region with Medtronic transvenous defibrillation leads. No claims of safety and performance can be made with regard to other acutely or chronically implanted lead systems that are not manufactured by Medtronic.

Caution: Lead coils and Active Can electrodes that are in contact during a high-voltage therapy may cause electrical current to bypass the heart, possibly damaging the device and leads. While the device is connected to the leads, verify that therapeutic electrodes, stylets, or guide wires are not touching or connected by any material that may conduct electricity. Move objects made from conductive materials (for example, an implanted guide wire) well away from all electrodes before delivering a high-voltage shock.

Caution: Do not implant the device after the “Use by” date on the package label. Device longevity may be reduced.

Caution: Do not immerse the device in fluid or flush the connector ports at the time of implant. Doing so could

adversely affect the performance of the device and lead system.

4.1.4 How to prepare the device for implant

Before opening the sterile package, perform the following steps to prepare the device for implant:

1. Interrogate the device and print an Initial Interrogation Report. Caution: If the programmer reports that an electrical reset occurred, do not implant the device. Contact a Medtronic representative.

2. To confirm that the device is acceptable for implant, check the status of the Remaining Longevity estimate on the Quick Look II screen. The Remaining Longevity estimate graphic is gray if the battery status is not acceptable for implant and it is green if the battery status is acceptable for implant. If the device has been exposed to low temperatures, the battery voltage can be temporarily lower and the charge time can increase. If the battery status is unacceptable, store the device at room temperature for 48 hours and check the battery status again to determine if the device is acceptable for implant. If an acceptable battery status cannot be obtained after 48 hours, contact a Medtronic representative. Note: If the Remaining Longevity estimate graphic on the Quick Look II screen is gray, indicating that the battery status is unacceptable, do not charge the capacitors.

3. Select Params > Data Collection Setup > Device Date/Time… to set the internal clock of the device to the correct date and time.

4. Program the therapy and pacing parameters to values appropriate for the patient. Ensure that tachyarrhythmia detection is not programmed to On.

Notes:

●

Do not enable a pacing feature that affects the pacing rate (for example, Ventricular Rate Stabilization) before implanting the device. Doing so may result in a pacing rate that is faster than expected.

●

Patient information typically is entered at the time of initial implant, and it can be revised at any time.

4.2 Selecting and implanting the leads

Use the guidelines in this section to select leads that are compatible with the device. The appropriate techniques for implanting the leads may vary according to physician preference and the patient’s anatomy or physical condition. Consult the technical manuals supplied with the leads for specific implant instructions.

A complete SureScan defibrillation system is required for use in the MR environment. Any other combination may result in a hazard to the patient during an MRI scan. Before performing an MRI scan,

refer to the MRI technical manual for MRI-specific warnings and precautions. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com.

A complete dual-chamber SureScan defibrillation system includes an Evera MRI S DR SureScan ICD with a SureScan right atrial pacing lead and a SureScan defibrillation lead.

4.2.1 Selecting the leads

Do not use any lead with this device without first verifying lead and connector compatibility.

The device typically is implanted with the following leads:

●

1 quadripolar/tripolar transvenous lead with a DF4-LLHH or DF4-LLHO connector in the right ventricle (RV) for sensing and pacing, and for cardioversion and defibrillation therapies

●

1 bipolar transvenous lead with an IS-1 connector in the atrium (A) for sensing and pacing. Use of a bipolar atrial lead with ring and tip electrodes spaced ≤10 mm apart to reduce far-field R-wave sensing is recommended.

4.2.2 How to verify lead and connector compatibility

Warning: Verify lead and connector compatibility before using a lead with this device. Using an incompatible lead

may damage the connector, resulting in electrical current leakage or resulting in an intermittent electrical connection.

Note: Medtronic 3.2 mm low-profile leads are not directly compatible with the device IS-1 connector port.

Note: Lead adaptors compromise the ability to safely scan the SureScan defibrillation system during an MRI scan.

Patients with lead adaptors are contraindicated for an MRI scan. Refer to the MRI technical manual for additional information.

Use the information in Table 1 to select a compatible lead.

Table 1. Lead and connector compatibility

Connector port (electrodes) Primary lead

RV (RVtip, RVring, RVcoil, SVC coil) DF4-LLHH or DF4-LLHOa quadripolar/tripolar

A (Atip, Aring) IS-1b bipolar

DF4-LLHH and DF4-LLHO refer to the international standard ISO 27186, where the lead connector contacts are defined as low voltage (L), high voltage (H), or open (O).

IS-1 refers to the international standard ISO 5841-3.

4.2.3 Implanting the leads

Implant the leads according to the instructions in the technical manuals supplied with the leads unless suitable chronic leads are already in place.

Warning: Pinching the lead can damage the lead conductor or the insulation, which may cause unwanted high-voltage therapies or the loss of sensing or pacing therapy.

Transvenous leads – If you use a subclavian approach to implant a transvenous lead, position the lead laterally to avoid pinching the lead body between the clavicle and the first rib.

4.3 Testing the lead system

After the leads are implanted, test the lead system to verify that the sensing and pacing values are acceptable.

4.3.1 Considerations for testing the lead system

Bipolar leads – When measuring sensing and pacing values, measure between the tip (cathode) and ring or coil

(anode) of each bipolar pacing/sensing lead.

Lead positioning – Final lead positioning should attempt to optimize pacing threshold, sensing, and defibrillation threshold if appropriate.

4.3.2 How to verify and save the sensing and pacing values

Medtronic recommends that you use a Medtronic analyzer to perform sensing and pacing measurements. When the analyzer and the device sessions are running concurrently, you can export the saved lead measurements from the analyzer session into the patient information parameters in the device session. Refer to the analyzer technical manual for detailed procedures about performing the lead measurements.

Note: If you perform the lead measurements using an implant support instrument other than a Medtronic analyzer, enter the measurements in the device session manually.

Note: The intracardiac EGM that is telemetered from the device cannot be used to assess sensing directly.

1. From the device session, launch a new analyzer session by selecting the Analyzer icon, which is located on the task bar.

2. Measure the EGM amplitude, slew rate, and capture threshold using a Medtronic Analyzer.

3. Use the information in Table 2 to verify that the measured values are acceptable. Note: The measured pacing lead impedance is a reflection of measuring equipment and lead technology. Refer to the lead technical manual for acceptable impedance values and for additional information about sensing and pacing values.

4. Select [Save…] at the bottom of the column that corresponds to the lead you are testing.

5. In the Lead field, select the type of lead you are testing and then select [Save].

6. Select [View Saved…].

7. Select the saved measurements that you want to export. You can select a single measurement for each lead type.

8. Select [Export] and [Close]. The selected measurements are exported to the Implant… field on the Patient Information screen in the device session.

9. Select the Device icon on the task bar to return to the device session.

10. Select Patient > Patient Information and then select [Program] to program the imported values into the device memory.

Table 2. Acceptable sensing and pacing values

Measurements required Acute transvenous leads Chronic leads

P-wave EGM amplitude (atrial) ≥2 mV ≥1 mV

R-wave EGM amplitude (RV) ≥5 mV ≥3 mV

Slew rate

≥0.5 V/s (atrial) ≥0.3 V/s (atrial)

≥0.75 V/s (RV) ≥0.5 V/s (RV)

Table 2. Acceptable sensing and pacing values (continued)

Measurements required Acute transvenous leads Chronic leads

Capture threshold (0.5 ms pulse width)

≤1.5 V (atrial) ≤3.0 V (atrial)

≤1.0 V (RV) ≤3.0 V (RV)

Chronic leads are leads implanted for 30 days or more.

4.4 Connecting the leads to the device

The following procedure describes how to connect the lead to the device, how to confirm that the lead connector is fully inserted in the connector block, and how to verify that the lead connection is secure.

Warning: After connecting the leads, verify that the lead connections are secure by gently tugging on each lead. A loose lead connection may result in inappropriate sensing, which can cause inappropriate arrhythmia therapy or a failure to deliver arrhythmia therapy.

Caution: Use only the torque wrench supplied with the device. The torque wrench is designed to prevent damage to the device from overtightening a setscrew.

See Figure 1 for information about the lead connector ports on the device.

Figure 1. Lead connector ports

1 IS-1 connector port, A

3 Device Active Can electrode

2 DF4-LLHH connector port, RV

4.4.1 How to connect a lead to the device

1. Insert the torque wrench into the appropriate setscrew. a. If the setscrew obstructs the port, retract the setscrew by turning it counterclockwise until the port is clear.

Take care not to disengage the setscrew from the connector block (see Figure 2).

b. Leave the torque wrench in the setscrew until the lead connection is secure to allow a pathway for venting

trapped air when the lead connector is inserted into the connector port (see Figure 2).

Figure 2. Inserting the torque wrench into the setscrew

2. Insert the lead connector into the connector port, keeping twisting to a minimum. Insert the lead connector

until the lead connector pin is visible in the pin viewing area. No sealant is required.

3. Confirm that the lead is fully inserted into the connector pin cavity by viewing the device connector block from

the side.

a. For the DF4-LLHH connector port, the color band on the tip of the lead connector pin is visible in the pin

viewing area when the pin is fully inserted (see Figure 3).

Figure 3. Confirming the DF4-LLHH or DF4-LLHO lead connection

b. For the IS-1 connector port, the lead connector pin should be clearly visible beyond the setscrew block

(see Figure 4).

c. For the IS-1 connector port, the lead connector ring should be completely inside the spring contact block.

There is no setscrew in this location (see Figure 4).

Figure 4. Confirming the IS-1 lead connection

4. Tighten the setscrew by turning it clockwise until the torque wrench clicks. Remove the torque wrench.

5. Gently tug on the lead to confirm a secure fit. Do not pull on the lead until the setscrew has been tightened.

6. Repeat these steps for each lead.

4.5 Performing ventricular defibrillation threshold tests

Ventricular defibrillation operation and effectiveness of the implanted lead system may be tested by inducing VF using either the T-Shock or the 50 Hz Burst method and then allowing the device to detect and treat the VF using the programmed automatic therapies. Follow your preferred method to establish that an adequate sensing safety margin and an adequate defibrillation safety margin exist.

The decision to induce VF for testing the ventricular defibrillation operation and implanted lead system effectiveness should be carefully considered for each patient. Physicians should use their discretion in deciding whether to test or how to test for an adequate safety margin.

4.5.1 High-voltage implant values

See Table 3 for information about the measured high-voltage therapy values that are recommended at implant.

Table 3. High-voltage (HV) therapy values recommended at implant

Measurement Acute or chronic leads

HV delivery pathway impedance 20–200 Ω

Defibrillation threshold ≤25 J

4.5.2 How to prepare for defibrillation threshold testing

Warning: Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or

induced tachyarrhythmias may occur during device testing, implant procedures, and post-implant testing.

1. Establish telemetry between the device and programmer, and start a patient session. If you are using wireless

telemetry, verify that at least 3 of the green lights on the wireless telemetry icon are illuminated. Interrogate the device if it has not been interrogated.

2. Select the Params icon, select the VF Therapies field, and then select [Shared Settings…]. Program the

Active Can/SVC Coil parameter to On or Off, as is appropriate for the patient.

3. Observe the Marker Channel annotations to verify that the device is sensing properly.

4. Perform a manual Lead Impedance Test to verify defibrillation lead connections. For information about

acceptable impedance values, refer to the lead technical manual and see Table 3. Perform this test with the device in the surgical pocket. Keep the surgical pocket very moist. If the lead impedance is out of range, perform one or more of the following tasks:

●

Recheck the lead connections and lead electrode placement.

●

Inspect the EGM for abnormalities.

●

Repeat the manual Lead Impedance Test.

4.5.3 How to perform defibrillation threshold testing using T-Shock

1. Select Tests > EP Study.

2. Select T-Shock from the list of EP Study functions.

3. Confirm that the Resume at DELIVER check box is selected to resume arrhythmia detection after the

induction is delivered. Note: During a wireless telemetry session, you cannot deliver a T-Shock induction when there is a magnet or programming head over the device and the Resume at DELIVER check box is selected. If an error message appears, remove the magnet or programming head or clear the Resume at DELIVER check box.

4. Select [Adjust Permanent…].

5. Set the Energy parameter for VF Therapy Rx1 to 10 J less than the desired final programmed value. Set VF

Therapies Rx2 through Rx6 to the maximum value.

6. Set the RV Sensitivity parameter to a value that results in an adequate safety margin for detecting VF. For a

final programmed RV Sensitivity of 0.3 mV, an adequate safety margin typically is attained by setting the value to 1.2 mV during testing.

7. Set VF Enable to On. This also automatically sets the AF/Afl, Sinus Tach, and Wavelet features to On.

8. Select [PROGRAM].

9. Select [Close].

10. Select the Enable check box.

11. Select [DELIVER T-Shock]. If necessary, select [ABORT] to abort the induction or any therapy in progress.

12. Observe the Live Rhythm Monitor for proper detection, therapy, and post-shock sensing.

13. To review the stored data for the induced episode, select [Retrieve Data…]. To view more details, print a Last VT/VF with EGM report or select Data > Clinical Diagnostics > Arrhythmia Episodes to view the data on the programmer.

14. Select [Adjust Permanent…] to program a new VF Therapy Rx1 energy level or to change the Pathway, if desired.

15. Wait until the on-screen timer reaches 5 min; then repeat Step 10 through Step 15 as needed.

16. Before closing the pocket, select the Params icon and program VF Detection, FVT Detection, and VT Detection to Off.

4.5.4 How to perform defibrillation threshold testing using 50 Hz Burst

1. Select Tests > EP Study.

2. Select 50 Hz Burst from the list of EP Study functions.

3. Select [RV] in the Select Chamber box.

4. Confirm that the Resume at BURST check box is selected to resume arrhythmia detection after the induction is delivered. Note: During a wireless telemetry session, you cannot deliver a 50 Hz Burst induction when there is a magnet or programming head over the device and the Resume at BURST check box is selected. If an error message appears, remove the magnet or programming head, or clear the Resume at BURST check box.

5. Select [Adjust Permanent…].

6. Set the Energy parameter for VF Therapy Rx1 to 10 J less than the desired final programmed value. Set VF Therapies Rx2 through Rx6 to the maximum value.

7. Set the RV Sensitivity parameter to a value that results in an adequate safety margin for detecting VF. For a final programmed RV Sensitivity of 0.3 mV, an adequate safety margin typically is attained by setting the value to 1.2 mV during testing.

8. Set VF Enable to On. This also automatically sets the AF/Afl, Sinus Tach, and Wavelet features to On.

9. Select [PROGRAM].

10. Select [Close].

11. Press and hold the [50 Hz BURST Press and Hold] button. Remove the touch pen from the [50 Hz BURST Press and Hold] button to automatically abort the induction or therapy.

12. Observe the Live Rhythm Monitor for proper detection, therapy, and post-shock sensing.

13. To review the stored data for the induced episode, select [Retrieve Data…]. To view more details, print a Last VT/VF with EGM report, or select Data > Clinical Diagnostics > Arrhythmia Episodes to view the data on the programmer.

14. Select [Adjust Permanent…] to program a new VF Therapy Rx1 energy level or to change the Pathway, if desired.

15. Wait until the on-screen timer reaches 5 min, then repeat Step 11 through Step 15 as needed.

16. Before closing the pocket, select the Params icon and program VF Detection, FVT Detection, and VT Detection to Off.

4.6 Positioning and securing the device

Caution: Program tachyarrhythmia detection to Off or Monitor to avoid inappropriate detection or therapy delivery

while closing the surgical pocket.

Note: Implant the device within 5 cm (2 in) of the surface of the skin to optimize post-implant ambulatory monitoring. The side of the device engraved with the Medtronic logo should face toward the skin so it is easier for the patient to hear the alert tones. In addition, this orientation is most compatible with the device PhysioCurve Design.

4.6.1 How to position and secure the device

1. Verify that each lead connector pin is fully inserted into the connector port and that all setscrews are tight.

2. To prevent twisting of the lead body, rotate the device to loosely wrap the excess lead length (see Figure 5). Do not kink the lead body.

Figure 5. Rotating the device to wrap the leads

3. Place the device and the leads into the surgical pocket.

4. Use nonabsorbable sutures to secure the device within the pocket and minimize post-implant rotation and migration. Use a surgical needle to penetrate the suture holes on the device (see Figure 6).

Figure 6. Locating the suture holes

5. Suture the pocket incision closed.

4.7 Completing the implant procedure

Warning: Do not program the Other 1:1 SVTs feature to On until the atrial lead has matured (approximately 1

month after implant). If the atrial lead dislodges and migrates to the ventricle, the Other 1:1 SVTs feature could inappropriately withhold detection and therapy.

Warning: Do not program AT/AF Detection to On or enable automatic atrial ATP therapies until the atrial lead has matured (approximately 1 month after implant). If the atrial lead dislodges and migrates to the ventricle, the device could inappropriately detect AT/AF, deliver atrial ATP to the ventricle, and possibly induce a life-threatening ventricular tachyarrhythmia.

4.7.1 How to complete programming the device

1. Enable tachyarrhythmia detection and the desired tachyarrhythmia therapies.

2. Perform a final VF induction, and allow the implanted system to detect and treat the tachyarrhythmia.

3. Verify that the pacing, detection, and therapy parameters are programmed to values that are appropriate for the patient.

4. Enter the patient’s information. Note: Be sure to use the Patient information screen to enter complete information about the implanted leads. Be sure to use the MRI SureScan System/Other Hardware screen to enter complete information about other hardware implanted in the patient, including abandoned devices or leads, and lead extenders or adaptors. This information will be used in the future if the patient needs to be evaluated for an MRI scan. For more information, see the reference manual.

5. Configure the Medtronic CareAlert feature.

6. Program the Data Collection Setup parameters.

4.7.2 How to assess the performance of the device and the leads

After implanting the device, x-ray the patient as soon as possible to verify device and lead placement. Before the patient is discharged from the hospital, assess the performance of the implanted device and leads.

1. Monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period.

2. If any tachyarrhythmia therapies are enabled while the patient is in the hospital, interrogate the device after any spontaneous episodes to evaluate the detection and therapy parameter settings.

3. If the patient has not experienced spontaneous episodes, you may induce tachyarrhythmias using the non-invasive EP study features to further assess the performance of the system.

4. Check the pacing and sensing values, and adjust the values if necessary.

5. Demonstrate the alert tones.

6. Interrogate the device and create a Final Report to document the postoperative programmed device status.

4.8 Replacing a device

To retain the ability to safely scan the SureScan defibrillation system during future MRI scans, refer to the MRI technical manual for additional information.

Warning: Leads other than SureScan leads may be used with the DDMC3D4 device, but if leads other than

SureScan leads are used, the system is contraindicated for MRI scans. Before performing an MRI scan, refer to the MRI technical manual for additional information.

Warning: Abandoned leads or previously implanted non-MRI labeled leads compromise the ability to safely scan the SureScan defibrillation system during future MRI scans. When implanting a SureScan defibrillation system, consider the risks associated with removing previously implanted leads before removing the leads to maintain the ability to safely scan the SureScan defibrillation system.

Warning: Keep external defibrillation and pacing equipment nearby for immediate use. The patient does not receive defibrillation or pacing therapy from the device when the lead is disconnected.

Caution: Disable tachyarrhythmia detection to avoid inappropriate therapy delivery while explanting the device.

Note: To meet the implant requirements, you may need to reposition or replace the chronic leads, or add a third

high-voltage electrode. If you use a high-voltage lead in the RV that is not compatible with the DF4-LLHH connector port, an adaptor must be used. Contact your Medtronic representative for information about compatible lead adaptors.

Note: Any unused leads that remain implanted must be capped with a lead pin cap to avoid transmitting electrical signals. Contact your Medtronic representative for information about lead pin caps. Any capped or unused leads are considered abandoned leads in the MRI conditions for use, and their presence will contraindicate the system for MRI scanning.

4.8.1 How to explant and replace a device

1. Disable tachyarrhythmia detection to avoid potential inappropriate shocks to the patient or the implanter while explanting the device.

2. Program the device to a mode that is not rate responsive to avoid potential rate increases while explanting the device.

3. Dissect the leads and the device free from the surgical pocket. Do not nick or breach the lead insulation.

4. Use a torque wrench to loosen the setscrews in the connector block.

5. Gently pull the leads out of the connector ports.

6. Evaluate the condition of each lead (see Section 4.3, “Testing the lead system”, page 21). Replace a lead if the electrical integrity is not acceptable or if the lead connector pin is pitted or corroded. If you explant the lead, return it to Medtronic for analysis and disposal.

7. Connect the leads to the replacement device (see Section 4.4, “Connecting the leads to the device”, page 22). Note: Lead adaptors may be needed to connect the leads to the replacement device. Contact a Medtronic representative for information about compatible lead adaptors. Note: Lead adaptors compromise the ability to safely perform an MRI scan on the SureScan defibrillation system in the future. Devices connected with lead adaptors are contraindicated for an MRI scan. Refer to the MRI technical manual for additional information.

8. Evaluate defibrillation effectiveness using the replacement device (see Section 4.5, “Performing ventricular defibrillation threshold tests”, page 24).

9. Position and secure the device in the surgical pocket, and suture the pocket incision closed (see Section 4.6, “Positioning and securing the device”, page 26).

10. Contact Medtronic for Return Mailer Kits to return explanted devices for analysis and disposal. See the back cover for addresses. Note: Disposal of explanted devices or leads is subject to local, state, and federal regulations.

5 Product specifications

5.1 Physical characteristics

Table 4. Physical characteristics

Volume

Mass 78 g

H x W x D 68 mm x 51 mm x 13 mm

Surface area of device can 57 cm

Radiopaque ID

Medtronic radiopaque identifier

34 cm

PFZ

Materials in contact with human tissue

Titanium, polyurethane, silicone rubber

Battery Hybrid CFx lithium/silver vanadium oxide

Volume with connector ports unplugged.

The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a fluoroscopic image of the device.

These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation.

Figure 7. Connector ports and suture holes

1 IS-1 connector port, A 2 DF4-LLHH connector port, RV

3 Device Active Can electrode 4 Suture holes

5.2 Replacement indicators

The Remaining Longevity estimate, replacement status, and battery voltage appear on the programmer display and on printed reports. The Recommended Replacement Time (RRT) and the End of Service (EOS) conditions are listed in Table 5.

Table 5. Replacement indicators

Recommended Replacement Time (RRT) <2.73 V on 3 consecutive daily automatic measure-

ments

End of Service (EOS) 3 months after RRT

Remaining Longevity – The Remaining Longevity estimate displays the estimated time remaining until device RRT.

RRT (Recommended Replacement Time) – The programmer displays the RRT battery status to indicate that replacement of the device is recommended.

RRT date – The programmer displays the date when the battery reached RRT on the Quick Look II and Battery and Lead Measurements screens.

EOS (End of Service) – The programmer displays the EOS battery status to indicate that the device should be replaced immediately and may not operate per specifications.

Replace at EOS – If the programmer indicates that the device is at EOS, replace the device immediately.

Prolonged Service Period – The Prolonged Service Period (PSP) is the time between the RRT and EOS. The

PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 bpm, 2.5 V atrial and RV pacing amplitude, 0.4 ms pulse width; 600 Ω pacing load; and 6 full-energy charges. If the device exceeds these conditions, the EOS may be indicated before the end of 3 months.

5.3 Projected service life

The projected service life in years for the device is shown in Table 6 and Table 7. The data is based on pacing outputs programmed to the specified mode, the specified pacing amplitude, 0.4 ms pulse width, and 60 bpm pacing rate.

The service life projections are based on the following assumptions:

●

Semi-annual maximum energy charging frequency

●

Pre-arrhythmia EGM storage programmed to On for a 6-month period (two 3-month follow-up intervals), over the entire life of the device

●

3 hours of wireless telemetry during implant

●

A quarterly schedule of Medtronic patient monitor remote transmissions

●

1 hour of in-office wireless telemetry annually

●

Typical shelf storage time before implant

Projected service life estimates are based on accelerated battery discharge data and device modeling as specified. Do not interpret these values as precise numbers.

Table 6. Projected service life in years

Projected service life in years

Pacing mode, percent

pacing Pacing amplitude

DDD, 0% 2.5 V

3.5 V

DDD, 15% 2.5 V

3.5 V

DDD, 50% 2.5 V

3.5 V

DDD, 100% 2.5 V

3.5 V

Pacing impedance

500 Ω

9.7

9.6

9.1

8.7

8.3

7.1

7.3

5.7

Pacing impedance

600 Ω

9.7

9.6

9.2

8.8

8.5

7.4

7.6

6.1

Table 7. Projected service life in years, with the Pacing Mode programmed to AAI<=>DDD

Projected service life in years

Pacing mode, percent

pacing Pacing amplitude

AAI<=>DDD (MVP mode)

Pacing impedance

2.5 V

3.5 V

500 Ω

8.9

8.2

600 Ω

Pacing impedance

9.0

8.3

50% atrial/5% ventricular

5.3.1 Projected service life considerations

Additional full-energy charges – Each additional full-energy charge due to therapy shock or device testing

reduces projected service life by approximately 33 days.

Pre-arrhythmia EGM storage – Full-time use of Pre-arrhythmia EGM storage reduces projected service life by approximately 2.4 months per year, or 20%.

Medtronic patient monitor remote transmissions – Additional Medtronic patient monitor remote transmissions reduce projected service life. For example, a DR patient who received 0% atrial and ventricular

pacing, DDD mode, with 600 Ω impedance would expect 9.7 years projected service life. Projected service life reductions for more frequent remote transmission rates are as follows:

●

Monthly transmissions over the life of the device reduce projected service life by 80 days, or 2%.

●

Weekly transmissions over the life of the device reduce projected service life by 381 days, or 11%.

●

Daily transmissions over the life of the device reduce projected service life by 1549 days, or 44%

●

A single additional transmission reduces projected service life by approximately 0.8 days, or 0.02%.

Wireless telemetry – Each additional hour of wireless telemetry use (in-office or implant) reduces the projected service life by approximately 7.6 days, or 0.25%.

Shelf storage time – Maximum shelf storage time of 18 months reduces projected service life by approximately

6.4%.

5.4 Energy levels and typical charge times

Energy levels – Stored energy is always greater than the delivered energy. Stored energy is derived from the peak

capacitor charge.

Typical charge times – The most recent capacitor charge time appears on the programmer display and on printed reports. You can evaluate charge time using the Charge/Dump Test.

Table 8. Maximum energy levels and typical full energy charge times

Maximum programmed energy 35 J

Maximum delivered energy

Maximum stored energy

Typical charge time at Beginning of Service (BOS)

Typical charge time at Recommended Replacement Time (RRT)

Energy delivered at connector block into a 50 Ω load.

For 35 J programmed energy, delivered energy exceeds 35 J.

Energy stored at charge end on capacitor.

Charge time during a nonwireless telemetry session may be slightly higher.

a,b

36 J

42 J

8.3 s

12.3 s

5.5 Magnet application

When a magnet is placed near the device, tachyarrhythmia detection is suspended and no tachyarrhythmia therapies are delivered. Alert tones sound if programmed. The device ignores the magnet in the programmer head when telemetry communication is established through the programmer head. Before implant and for the first 6 hours after implant, the device does not sound audible tones when a magnet is placed over the device.

Note: If MRI SureScan is programmed to On, tachyarrhythmia detection and Medtronic CareAlerts (including audible alerts) are suspended.

6 Device parameters

6.1 Emergency settings

Table 9. Emergency settings and default values

Parameter Selectable values

Defibrillation

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 25; 26; 28; 30;

32; 35 J

Pathway

MRI SureScan Off

Cardioversion

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 25; 26; 28; 30;

Pathway

MRI SureScan Off

Fixed Burst

Interval 100; 110 … 350 … 600 ms

RV Amplitude 8 V

RV Pulse Width 1.5 ms

MRI SureScan Off

VVI Pacing

Pacing Mode VVI

Lower Rate 70 bpm

RV Amplitude

RV Pulse Width

V. Blank Post VP 240 ms

V. Rate Stabilization Off

MRI SureScan Off

If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the highvoltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway.

If the programmed RV Amplitude is 8 V, VVI pacing is delivered at 8 V with a pulse width of 1.2 ms.

B>AX

32; 35 J

B>AX

6 V

1.5 ms

6.2 Tachyarrhythmia detection parameters

Warning: Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the

sensitivity threshold to its minimum (most sensitive) setting of 0.15 mV.

Table 10. Tachyarrhythmia detection parameters

Parameter Programmable values Shipped Reset

AT/AF Detection On; Monitor Monitor Monitor

Zones 1 ; 2 — —

AT/AF Interval (Rate)

150; 160 … 350 … 450 ms 350 ms 350 ms

Fast AT/AF Interval (Rate)a150; 160 … 200 … 250 ms — —

VF Detection

VF Interval (Rate)

VF Initial Beats to Detect 12/16; 18/24; 24/32; 30/40 ; 45/60;

On ; OFF OFF On

240; 250 … 320 … 400 ms 320 ms 320 ms

30/40 30/40 60/80; 75/100; 90/120; 105/140; 120/160

VF Beats to Redetect 6/8; 9/12; 12/16 ; 18/24; 21/28;

12/16 12/16 24/32; 27/36; 30/40

FVT Detection OFF ; via VF; via VT OFF OFF

FVT Interval (Rate)

200; 210 … 240 … 600 ms — —

VT Detection On; OFF OFF OFF

VT Interval (Rate)

280; 290 … 360 … 650 ms 360 ms 400 ms

VT Initial Beats to Detect 12; 16 … 52; 76; 100 16 16

VT Beats to Redetect 8; 12 … 52 12 12

VT Monitor Monitor ; Off Off Off

VT Monitor Interval (Rate)a280; 290 … 450 … 650 ms 450 ms 450 ms

Monitored VT Beats to

16; 20; 24; 28; 32 … 56; 80; 110; 130 32 32

Detect

PR Logic/Wavelet

AF/Afl

Sinus Tach

On ; Off Off Off

Other 1:1 SVTs On; Off Off Off

Wavelet…

Wavelet

On ; Off; Monitor Off Off

Template [date] None None

Match Threshold 40; 43; 46 …70 … 97% — —

Auto Collection On ; Off — —

SVT V. Limit

240; 250; 260 … 650 ms — —

Other Enhancements

Stability

Off ; 30; 40 …100 ms Off Off

Onset…

Onset Off ; On; Monitor Off Off

Onset Percent 72; 75; 78; 81 ; 84; 88; 91; 94; 97% — —

Table 10. Tachyarrhythmia detection parameters (continued)

Parameter Programmable values Shipped Reset

High Rate Timeout…

VF Zone Only Off ; 0.25; 0.5; 0.75; 1; 1.25; 1.5; 1.75;

Off Off 2; 2.5; 3; 3.5; 4; 4.5; 5 min

All Zones Off ; 0.5; 1; 1.5 … 5; 6; 7 … 20; 22; 24;

— — 26; 28; 30 min

TWave On ; Off On Off

RV Lead Noise…

RV Lead Noise On; On+Timeout ; Off On+Timeout Off

Timeout 0.25; 0.5; 0.75 … 2 min 0.75 min —

Sensitivity

c,d

Atrial

0.15; 0.30 ; 0.45; 0.60; 0.90; 1.20;

0.3 mV 0.3 mV

1.50; 1.80; 2.10; 4.00 mV

c,d

The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device

0.15; 0.30 ; 0.45; 0.60; 0.90; 1.20 mV 0.3 mV 0.3 mV

uses this truncated interval value when applying the programmed criteria and calculating interval averages.

The AF/Afl, Sinus Tach, and Wavelet features are automatically set to On when VF Detection is set to On.

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.

Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity threshold to its minimum (most sensitive) setting of 0.15 mV.

6.3 Atrial tachyarrhythmia therapy parameters

Table 11. Atrial tachyarrhythmia therapy parameters

Parameter Programmable values Shipped Reset

Anti-Tachy Pacing (ATP)

AT/AF Rx Status On; Off Off Off

Therapy Type 50 Hz; Ramp; Burst+

Rx1: Ramp Rx2: Burst+ Rx3: 50 Hz

Fast AT/AF Rx Status On; Off — —

Therapy Type 50 Hz; Ramp; Burst+

Rx1: Ramp Rx2: Burst+ Rx3: 50 Hz

Patient Activated CV

Patient Activated CV Sta-

On; Off Off Off

tus

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24;

25; 26; 28; 30; 32; 35 J

— —

Table 11. Atrial tachyarrhythmia therapy parameters (continued)

Parameter Programmable values Shipped Reset

Pathway

AX>B; B>AX — —

Automatic CV

AT/AF Automatic CV Sta-

On; Off Off Off

tus

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24;

— —

25; 26; 28; 30; 32; 35 J

Pathway

Fast AT/AF Automatic CV

AX>B; B>AX — —

On; Off — —

Status

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24;

— —

25; 26; 28; 30; 32; 35 J

Pathway

AX>B; B>AX — —

Shared CV

Minimum R-R Interval

Active Can/SVC Coil

400; 410 … 500 … 600 ms 500 ms 500 ms

Can+SVC On ; Can Off; SVC Off Can+SVC On Can+SVC On

Automatic CV Limits

Delivery Window Start

00:00; 01:00; 02:00; 03:00 … 23:00 — —

Time

Delivery Window Length 1 ; 2; 3; 4; 6; 8; 10; 12; 16; 20; 24 hr — —

Maximum shocks per day 1 ; 2; 3; 4; 5; No Limit — —

Episode Duration Before Rx Delivery

Episode Duration Before CV

0; 1; 2; 3; 4; 5; 7; 10; 15; 20; 25; 30; 40; 50 min;

— —

1; 2; 3; 4; 5; 6 ; 12; 24; 48; 72 hr; 7 days

50 Hz Burst parameters

50 Hz Burst Duration 0.5; 1 ; 2; 3 s — —

# Sequences 1; 2 … 10 — —

Burst+ parameters

Initial # S1 Pulses 1; 2 … 15 ; 20; 25 — —

A-S1 Interval (%AA) 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88;

— —

91 ; 94; 97%

S1-S2 (%AA) 28; 31; 34; 38; 41 … 59; 63; 66; 69 …

— —

84 ; 88; 91; 94; 97%; Off

S2-S3 Decrement 0; 10 ; 20 … 80 ms; Off — —

Interval Decrement 0; 10 … 40 ms — —

# Sequences 1; 2 … 6 … 10 — —

Table 11. Atrial tachyarrhythmia therapy parameters (continued)

Parameter Programmable values Shipped Reset

Ramp parameters

Initial # S1 Pulses 1; 2 … 6 … 15; 20; 25 — —

A-S1 Interval (%AA) 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88;

— —

91 ; 94; 97%

Interval Decrement 0; 10 … 40 ms — —

# Sequences 1; 2 … 8 ; 9; 10 — —

Stop Atrial Rx After (Shared)

Rx/Lead Suspect…

Disable Atrial ATP if it

Yes ; No — —

accelerates V. rate?

Disable all atrial therapies

Yes ; No No No if atrial lead position is suspect? (Atrial Lead Position Check)

Duration to stop 12; 24; 48 ; 72 hr; None — —

Episode Duration Before Rx Delivery

Episode Duration Before ATP

0; 1 ; 2; 3; 4; 5; 7; 10; 15; 20; 25; 30; 40;

50 min;

— —

1; 2; 3; 4; 5; 6; 12; 24 hr

Reactive ATP

Rhythm Change On ; Off — —

Time Interval Off; 2; 4; 7 ; 12; 24; 36; 48 hr — —

Shared A. ATP

A-A Minimum ATP Inter-

val

100; 110; 120; 130 … 400 ms 150 ms 150 ms

A. Pacing Amplitude 1; 2 … 6 ; 8 V 6 V 6 V

A. Pacing Pulse Width 0.1; 0.2 … 1.5 ms 1.5 ms 1.5 ms

VVI/VOO Backup Pacing Off; On (Always); On (Auto Enable) — —

VVI/VOO Backup Pacing

60; 70 … 120 bpm — —

Rate

The measured intervals are truncated to a 10 ms multiple (for example, 457 ms becomes 450 ms). The device uses this truncated interval value when applying the programmed criteria and calculating interval averages.

The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies. It also applies to T-Shock inductions.

6.4 Ventricular tachyarrhythmia therapy parameters

Table 12. Ventricular tachyarrhythmia therapy parameters

Parameter Programmable values Shipped Reset

VF Therapy parameters

VF Therapy Status On ; Off On On

Energy Rx1–Rx2: 0.4; 0.6 … 1.8; 2; 3 … 16; 18;

20; 22; 24; 25; 26; 28; 30; 32; 35 J Rx3–Rx6: 10; 11 … 16; 18; 20; 22; 24; 25; 26; 28; 30; 32; 35 J

Pathway

AX>B; B>AX Rx1–Rx4: B>AX Rx5–Rx6: AX>B

ATP… During Charging ; Before Charging; Off During Charg-

Deliver ATP if last 8 R-R >= 200; 210 … 240 … 300 ms 240 ms —

Therapy Type Burst ; Ramp; Ramp+ Burst —

ChargeSaver… On ; Off On —

Switch when number of

1 ; 2; 3; 4; 6; 8; 10 1 — consecutive ATP successes equals

Smart Mode On ; Off On —

VT/FVT Therapy parameters

35 J 35 J

B>AX B>AX

ing

Off

VT Therapy Status On; Off Off Off

FVT Therapy Status On; Off Off Off

Therapy Type CV; Burst; Ramp; Ramp+

— — Rx1: Burst Rx2–Rx6: CV

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24;

— — 25; 26; 28; 30; 32; 35 J VT Rx1–Rx2: 20 J VT Rx3–Rx6: 35 J FVT Rx1–Rx6: 35 J

Pathway

AX>B; B>AX

— — Rx1–Rx4: B>AX Rx5–Rx6: AX>B

Burst therapy parameters

Initial # Pulses 1; 2 … 8 … 15 VF Rx1: 8

—

Others: —

R-S1 Interval=(%RR) 50; 53; 56; 59; 63; 66 … 84; 88 ; 91; 94;

97%

Interval Dec 0; 10 … 40 ms VF Rx1: 10 ms

VF Rx1: 88%

Others: —

—

Others: —

Table 12. Ventricular tachyarrhythmia therapy parameters (continued)

Parameter Programmable values Shipped Reset

# Sequences 1; 2 … 10

VT Therapies: 3

VF Rx1: 1

Others: —

—

FVT Therapies: 1

Smart Mode

On; Off VF Rx1: On

—

Others: —

Ramp therapy parameters

Initial # Pulses 1; 2 … 8 … 15 — —

R-S1 Interval=(%RR) 50; 53; 56; 59; 63; 66 … 84; 88; 91 ; 94;

— — 97%

Interval Dec 0; 10 … 40 ms — —

# Sequences 1; 2 … 10

— — VT Therapies: 3 FVT Therapies: 1

Smart Mode

On; Off — —

Ramp+ therapy parameters

Initial # Pulses 1; 2; 3 … 15 — —

R-S1 Interval=(%RR) 50; 53; 56; 59; 63; 66 … 75 … 84; 88;

— — 91; 94; 97%

S1S2(Ramp+)=(%RR) 50; 53; 56; 59; 63; 66; 69 … 84; 88; 91;

— — 94; 97%

S2SN(Ramp+)=(%RR) 50; 53; 56; 59; 63; 66 … 84; 88; 91; 94;

— — 97%

# Sequences 1; 2 … 10

— — VT Therapies: 3 FVT Therapies: 1

Smart Mode

On; Off — —

Shared Settings…

V-V Minimum ATP Interval 150; 160 … 200 … 400 ms 200 ms 200 ms

V. Amplitude 1; 2 … 6; 8 V 8 V 8 V

V. Pulse Width 0.1; 0.2 … 1.5 ms 1.5 ms 1.5 ms

V. Pace Blanking 150; 160 … 240 … 450 ms 240 ms 240 ms

Active Can/SVC Coil

Progressive Episode Thera-

Can+SVC On ; Can Off; SVC Off Can+SVC On Can+SVC On

On; Off Off Off

pies

Confirmation+ On ; Off On On

Smart Mode is available only for Rx1– Rx4.

The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies. It also applies to T-Shock inductions.

6.5 Pacing parameters

Table 13. Modes, rates, and intervals

Parameter Programmable values Shipped Reset

Mode DDDR; DDD; AAIR<=>DDDR ;

AAI<=>DDD VVI

AAI<=>DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO

Mode Switch On ; Off On —

Lower Rate

30; 35 … 60 ; 70; 75 … 150 bpm 60 bpm 65 bpm

Upper Tracking Rate 80; 85 … 130 … 175 bpm 130 bpm —

Paced AV 30; 40 … 180 … 350 ms 180 ms —

Sensed AV 30; 40 … 150 … 350 ms 150 ms —

PVARP Auto ; 150; 160 … 500 ms Auto —

Minimum PVARP 150; 160 … 250 … 500 ms 250 ms —

A. Refractory Period 150; 160 … 310 … 500 ms — —

The corresponding Lower Rate Interval can be calculated as follows: Lower Rate Interval (ms) = 60,000/Lower Rate.

Table 14. Atrial parameters

Parameter Programmable values Shipped Reset

Atrial Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V 3.5 V —

Atrial Pulse Width 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 … 1.5 ms 0.4 ms —

Atrial Sensitivity

0.15; 0.3 ; 0.45; 0.6; 0.9; 1.2; 1.5; 1.8; 2.1;

0.3 mV 0.3 mV

4.0 mV

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.

Table 15. RV parameters

Parameter Programmable values Shipped Reset

RV Amplitude 0.5; 0.75 … 3.5 … 5; 5.5; 6; 8 V 3.5 V 6 V

RV Pulse Width 0.03; 0.06; 0.1; 0.2; 0.3; 0.4 … 1.5 ms 0.4 ms 1.5 ms

RV Sensitivity

0.15; 0.3 ; 0.45; 0.6; 0.9; 1.2 mV 0.3 mV 0.3 mV

RV Pace Polarity Bipolar; Tip to Coil Bipolar Bipolar

RV Sense Polarity Bipolar; Tip to Coil Bipolar Bipolar

This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing operations.

Table 16. Atrial Capture Management parameters

Parameter Programmable values Shipped Reset

Atrial Capture Management Adaptive ; Monitor; Off Adaptive —

Atrial Amplitude Safety

1.5x; 2.0x ; 2.5x; 3.0x 2.0x —

Margin

Atrial Minimum Adapted

1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V 1.5 V —

Amplitude

Atrial Acute Phase Remain-

Off; 30; 60; 90; 120 ; 150 days 120 days —

ing

Table 17. RV Capture Management parameters

Parameter Programmable values Shipped Reset

RV Capture Management Adaptive ; Monitor; Off Adaptive Off

RV Amplitude Safety Mar-

1.5x; 2.0x ; 2.5x; 3.0x 2.0x —

gin

RV Minimum Adapted

1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V 2 V —

Amplitude

RV Acute Phase Remaining Off; 30; 60; 90; 120 ; 150 days 120 days —

Table 18. Blanking periods

Parameter Programmable values Shipped Reset

PVAB Interval 10; 20 … 150 … 300 ms

100; 110 … 150 … 300 ms

PVAB Method Partial ; Partial+; Absolute

150 ms 150 ms

Partial Partial

A. Blank Post AP 150; 160 … 200 … 250 ms 200 ms —

A. Blank Post AS 100 ; 110 … 170 ms 100 ms 100 ms

V. Blank Post VP 150; 160 … 200 … 450 ms 200 ms 240 ms

V. Blank Post VS 120 ; 130 … 170 ms 120 ms 120 ms

When PVAB Method = Partial+ or Absolute

When PVAB Method = Partial

Programming the PVAB method to Absolute automatically resets the interval to 30 ms. If the PVAB method is programmed to Partial or Partial+, the interval resets to 150 ms.

Table 19. Rate Response Pacing parameters

Parameter Programmable values Shipped Reset

Upper Sensor Rate 80; 85 … 120 … 175 bpm 120 bpm —

ADL Rate 60; 65 … 95 … 170 bpm 95 bpm —

Rate Profile Optimization On ; Off On —

ADL Response 1; 2; 3 ; 4; 5 3 —

Exertion Response 1; 2; 3 ; 4; 5 3 —

Activity Threshold Low; Medium Low ; Medium High; High Medium Low —

Table 19. Rate Response Pacing parameters (continued)

Parameter Programmable values Shipped Reset

Activity Acceleration 15; 30 ; 60 s 30 s —

Activity Deceleration Exercise ; 2.5; 5; 10 min Exercise —

ADL Setpoint 5; 6 … 40; 42 … 80 18 —

UR Setpoint 15; 16 … 40; 42 … 80; 85 … 180 40 —

Table 20. Rate Adaptive AV parameters

Parameter Programmable values Shipped Reset

Rate Adaptive AV On; Off Off —

Start Rate 50; 55 … 90 … 145 bpm — —

Stop Rate 55; 60 … 130 … 175 bpm — —

Minimum Paced AV 30; 40 … 140 … 200 ms — —

Minimum Sensed AV 30; 40 … 110 … 200 ms — —

Table 21. Atrial Rate Stabilization parameters

Parameter Programmable values Shipped Reset

A. Rate Stabilization On; Off Off —

Maximum Rate 80; 85 … 100 … 150 bpm — —

Interval Percentage Increment

Table 22. Atrial Preference Pacing parameters

Parameter Programmable values Shipped Reset

A. Preference Pacing On; Off Off —

Maximum Rate 80; 85 … 100 … 150 bpm — —

Interval Decrement 30 ; 40 … 100; 150 ms — —

Search Beats 5; 10; 15; 20 ; 25; 50 — —

Table 23. Post Mode Switch Overdrive Pacing (PMOP) parameters

Parameter Programmable values Shipped Reset

Post Mode Switch On; Off Off —

Overdrive Rate 70; 75; 80 … 120 bpm — —

Overdrive Duration 0.5; 1; 2; 3; 5; 10 ; 20; 30; 60; 90; 120 min — —

12.5; 25 ; 50% — —

Table 24. Conducted AF Response parameters

Parameter Programmable values Shipped Reset

Conducted AF Response On; Off Off —

Response Level Low; Medium ; High — —

Maximum Rate 80; 85 … 110 … 130 bpm — —

Table 25. Ventricular Rate Stabilization parameters

Parameter Programmable values Shipped Reset

V. Rate Stabilization On; Off Off Off

Maximum Rate 80; 85 … 100 …120 bpm — —

Interval Increment 100; 110 … 150 … 400 ms — —

Table 26. Post VT/VF Shock Pacing parameters

Parameter Programmable values Shipped Reset

Post VT/VF Shock Pacing On; Off Off Off

Overdrive Rate 70; 75; 80 … 120 bpm — —

Overdrive Duration 0.5 ; 1; 2; 3; 5; 10; 20; 30; 60; 90; 120 min — —

Table 27. Post Shock Pacing parameters

Parameter Programmable values Shipped Reset

Post Shock A. Amplitude 1; 2; 3; 4 ; 5; 6; 8 V 4 V —

Post Shock A. Pulse Width 0.1; 0.2 … 1.5 ms 1.5 ms —

Post Shock V. Amplitude 1; 2 … 6 ; 8 V 6 V 6 V

Post Shock V. Pulse Width 0.1; 0.2 … 1.5 ms 1.5 ms 1.5 ms

Table 28. Rate Drop Response parameters

Parameter Programmable values Shipped Reset

Rate Drop Response

On; Off Off Off

Detection Type Drop ; Low Rate; Both — —

Drop Size 10; 15 … 25 … 50 bpm — —

Drop Rate 30; 40 … 60 … 100 bpm — —

Detection Window 10; 15; 20; 25; 30 s

— —

1 ; 1.5; 2; 2.5 min

Detection Beats 1; 2; 3 beats — —

Intervention Rate 70; 75 … 100 … 150 bpm — —

Intervention Duration 1; 2 … 15 min — —

When Rate Drop Response is programmed to On, the Lower Rate is automatically set to 45 bpm.

Table 29. Sleep parameters

Parameter Programmable values Shipped Reset

Sleep On; Off Off Off

Sleep Rate 30; 35 … 50 ; 55; 60; 70; 75 … 100 bpm — —

Bed Time 00:00; 00:10 … 22:00 … 23:50 — —

Wake Time 00:00; 00:10 … 07:00 … 23:50 — —

Table 30. Non-Competitive Atrial Pacing (NCAP) parameters

Parameter Programmable values Shipped Reset

Non-Comp Atrial Pacing On ; Off On —

NCAP Interval 200; 250; 300 ; 350; 400 ms 300 ms —

Table 31. MRI SureScan parameters

Parameter Programmable values Shipped Reset

MRI SureScan On; Off Off Off

MRI Pacing Mode DOO (Asynchronous); AOO (Asynchro-

— —

nous); VOO (Asynchronous); ODO (Off)

MRI Pacing Rate 60; 70; 75… 120 bpm — —

Table 32. Additional pacing features

Parameter Programmable values Shipped Reset

Rate Hysteresis Off ; 30; 40 … 80 bpm — Off

PMT Intervention On; Off Off —

PVC Response On ; Off On —

V. Safety Pacing On ; Off On —

6.6 Medtronic CareAlert parameters

Table 33. Clinical Management Alerts

Parameter Programmable values Shipped Reset

AT/AF Burden and Rate Settings…

Device Tone

Alert Urgency

AT/AF Daily Burden Alert Enable Off (Observation only) ; On Off (Observation

Avg. V. Rate During AT/AF Alert Enable

High ; Low — —

only)

Off (Observation only) ; On Off (Observation

only)

Off (Observation only)

Table 33. Clinical Management Alerts (continued)

Parameter Programmable values Shipped Reset

Patient Home Monitor

AT/AF Daily Burden Alert Ena-

ble

Avg. V. Rate During AT/AF Alert Enable

Off ; On — —

Shared (Device Tone and Patient Home Monitor)

AT/AF Daily Burden 0.5; 1; 2; 6 ; 12; 24 hours/day 6 hours/day 6 hours/day

Avg. V. Rate During AT/AF 90; 100 … 150 bpm 100 bpm 100 bpm

Daily Burden for Avg. V. Rate 0.5; 1; 2; 6 ; 12; 24 hours/day 6 hours/day 6 hours/day

Number of Shocks Delivered in an Episode…

Device Tone

Alert Enable - Urgency Off ; On-Low; On-High Off Off

Patient Home Monitor

Alert Enable

Off ; On — —

Shared (Device Tone and Patient Home Monitor)

Number of Shocks Threshold

1 ; 2; 3; 4; 5; 6 — —

All Therapies in a Zone Exhausted for an Episode.

Device Tone

Alert Enable - Urgency Off ; On-Low; On-High Off Off

Patient Home Monitor

Alert Enable

This parameter is displayed only if an associated alert has been enabled.

Alerts are programmable and transmittable to a monitor only when Patient Home Monitor is programmed to Yes.

Note that VF, VT, and FVT therapies could be delivered during a single episode (from initial detection until

Off ; On — —

episode termination).

Table 34. Lead/Device Integrity Alerts

Parameter Programmable values Shipped Reset

RV Lead…

Device Tone

Alert Urgency

Low; High High —

RV Lead Integrity Enable On ; Off On Off

RV Lead Noise Enable On ; Off On Off

Patient Home Monitor

RV Lead Integrity Enable

RV Lead Noise Enable

On ; Off — —

Table 34. Lead/Device Integrity Alerts (continued)

Parameter Programmable values Shipped Reset

Lead Impedance Out of Range…

Device Tone

Alert Urgency

Low; High High —

A. Pacing Impedance Enable On ; Off (Observation only) On Off (Observation

only)

RV Pacing Impedance Enable On ; Off (Observation only) On Off (Observation

only)

RV Defibrillation Impedance Enable

SVC Defibrillation Impedance Enable

On ; Off (Observation only) On Off (Observation

only)

On ; Off (Observation only) On Off (Observation

only)

Patient Home Monitor

A. Pacing Impedance Enable

RV Pacing Impedance Enable

RV Defibrillation Impedance Enable

SVC Defibrillation Impedance Enable

b,c

Off; On — —

Shared (Device Tone and Patient Home Monitor)

A. Pacing Impedance Less than 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

A. Pacing Impedance Greater

1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

than

RV Pacing Impedance Less than 200 ; 300; 400; 500 Ω 200 Ω 200 Ω

RV Pacing Impedance Greater

1000; 1500; 2000; 3000 Ω 3000 Ω 3000 Ω

than

RV Defibrillation Impedance

20 ; 30; 40; 50 Ω 20 Ω 20 Ω

Less than

RV Defibrillation Impedance

100; 130; 160; 200 Ω 200 Ω 200 Ω

Greater than

SVC Defibrillation Impedance

20 ; 30; 40; 50 Ω 20 Ω 20 Ω

Less than

SVC Defibrillation Impedance

100; 130; 160; 200 Ω 200 Ω 200 Ω

Greater than

Low Battery Voltage RRT…

Device Tone

Alert Enable - Urgency Off; On-Low; On-High On-High Off

Patient Home Monitor

Alert Enable

Off; On — —

Table 34. Lead/Device Integrity Alerts (continued)

Parameter Programmable values Shipped Reset

Excessive Charge Time EOS…

Device Tone

Alert Enable - Urgency Off; On-Low; On-High On-High Off

Patient Home Monitor

Alert Enable

Off; On — —

VF Detection Off, 3+ VF or 3+ FVT Rx Off.

Device Tone

Alert Enable Off; On-High On-High On-High

Patient Home Monitor

Alert Enable

This parameter is displayed only if an associated alert has been enabled.

If an SVC lead is not implanted, the alert will not sound.

Alerts are programmable and transmittable to a monitor only when Patient Home Monitor is programmed to Yes.

Off; On — —

Table 35. Shared parameters

Parameter Programmable values Shipped Reset

Patient Home Monitor Yes; No No No

Alert Time…

This parameter is displayed only if an associated alert has been enabled.

00:00; 00:10 … 08:00 … 23:50 08:00 08:00

6.7 Data collection parameters

Table 36. Data collection parameters

Parameter Programmable values Shipped Reset

LECG Source (Leadless ECG)

LECG Range

Can to SVC to Aring

±1; ±2 ; ±4; ±8; ±12; ±16; ±32 mV ±2 mV ±8 mV

(Leadless ECG)

EGM 1 Source RVtip to RVcoil; RVtip to RVring;

Atip to RVring; Atip to Aring ; Aring to RVring; Aring to RVcoil

EGM 1 Range ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV ±8 mV ±8 mV

EGM 2 (Wavelet) Source Can to RVcoil ; Can to RVring;

RVtip to RVcoil; RVtip to RVring; Can to SVC

EGM 2 (Wavelet) Range ±1; ±2; ±4; ±8; ±12 ; ±16; ±32 mV ±12 mV ±12 mV

EGM 3 Source RVtip to RVcoil; RVtip to RVring RVtip to RVring RVtip to RVring

EGM 3 Range ±1; ±2; ±4; ±8 ; ±12; ±16; ±32 mV ±8 mV ±2 mV

b,c

; RVcoil to Aring; Can

b,c

; RVcoil to SVC

Can to SVC Can to SVC

Atip to Aring Atip to Aring

Can to RVcoil Can to RVcoil

Table 36. Data collection parameters (continued)

Parameter Programmable values Shipped Reset

Monitored EGM1 and EGM2; EGM1 and

EGM3 ; EGM1 and LECG; EGM2

EGM1 and EGM3

EGM1 and

EGM2 and EGM3; EGM2 and LECG; EGM3 and LECG

Pre-arrhythmia EGM Off ; On - 1 month; On - 3 months; On

Off Off

Continuous

Device Date/Time

(Enter time and date) — —

Holter Telemetry Off ; 0.5; 1; 2; 4; 8; 16; 24; 36; 46 hr Off Off

This EGM channel displays far-field signals. To display an approximation of a surface ECG signal, choose the Can to SVC EGM source.

An SVC electrode must be present for this configuration.

If Can to SVC is selected, the EGM Range is automatically set to ±2 mV. The EGM Range is automatically set to ±8 mV for all other EGM Source options.

The times and dates stored in episode records and other data are determined by the Device Date/Time clock.

6.8 System test parameters

Table 37. System test parameters

Parameter Selectable values

Pacing Threshold Test parameters

Test Type Amplitude; Pulse Width

Chamber Atrium; RV

Decrement after 2; 3 … 15 pulses

RV Pace Polarity Bipolar; Tip to Coil

Modea (RV test) VVI; VOO; DDI; DDD; DOO

Modea (Atrium test) AAI; AOO; DDI; DDD; DOO

Lower Rate

RV Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V

RV Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms

A. Amplitude 0.25; 0.5 … 5; 5.5; 6; 8 V

A. Pulse Width 0.03; 0.06; 0.1; 0.2 … 1.5 ms

AV Delay 30; 40 … 350 ms

V. Pace Blanking 150; 160 … 450 ms

A. Pace Blanking 150; 160 … 250 ms

PVARP

Sensing Test parameters

Mode

AV Delay 30; 40 … 350 ms

Lower Rate

30; 35 … 60; 70; 75 … 150 bpm

150; 160 … 500 ms

AAI; DDD; DDI; VVI; ODO

30; 35 … 60; 70; 75 … 120 bpm

Table 37. System test parameters (continued)

Parameter Selectable values

Wavelet Test parameters

Match Threshold 40; 43 … 70 … 97

Mode

AAI; DDD; DDI; VVI; ODO

AV Delay 30; 40 … 350 ms

Lower Rate

The selectable values for this parameter depend on the programmed pacing mode.

When performing the test in DDD mode, the Lower Rate must be less than the programmed Upper Tracking

30; 35 … 60; 70; 75 … 120 bpm

Rate.

The selectable values for this parameter depend on the programmed PVAB values.

6.9 EP Study parameters

Table 38. T-Shock induction parameters

Parameter Selectable values

Resume at Deliver Enabled ; Disabled

Enable Enabled; Disabled

#S1 2; 3; 4; 5 ; 6; 7; 8

S1S1 300; 310 … 400 … 2000 ms

Delay 20; 30 … 300 … 600 ms

Energy 0.4; 0.6; 0.8; 1.0 … 1.8; 2; 3; 4 … 16; 18; 20; 22; 24; 25;

26; 28; 30; 32; 35 J

Waveform Monophasic ; Biphasic

Pathway

AX>B; B>AX

Table 39. 50 Hz Burst induction parameters

Parameter Selectable values

Resume at Burst Enabled ; Disabled

Chamber Atrium; RV

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms

VOO Backup (for atrial 50 Hz Burst) On; Off

Pacing Rate 60; 70 … 120 bpm

Table 39. 50 Hz Burst induction parameters (continued)

Parameter Selectable values

V. Amplitude

V. Pulse Width

The default value for this parameter is set according to the permanently programmed settings for bradycardia

a,b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V.

Table 40. Fixed Burst induction parameters

Parameter Selectable values

Resume at Burst Enabled ; Disabled

Chamber Atrium; RV

Interval 100; 110 … 600 ms

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms

VVI Backup (for atrial Fixed Burst) On; Off

Pacing Rate 60; 70 … 120 bpm

V. Amplitude

V. Pulse Width

The default value for this parameter is set according to the permanently programmed settings for bradycardia

a,b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V.

Table 41. PES induction parameters

Parameter Selectable values

Resume at Deliver Enabled ; Disabled

Chamber Atrium; RV

#S1 1; 2 … 8 … 15

S1S1 100; 110 … 600 … 2000 ms

S1S2 Off; 100; 110 … 400 … 600 ms

S2S3 Off ; 100; 110 … 400; 410 … 600 ms

S3S4 Off ; 100; 110 … 400; 410 … 600 ms

Amplitude 1; 2; 3; 4 ; 5; 6; 8 V

Pulse Width 0.10; 0.20 … 0.50 … 1.50 ms

VVI Backup (for atrial PES) On; Off

Pacing Rate 60; 70 … 120 bpm

Table 41. PES induction parameters (continued)

Parameter Selectable values

V. Amplitude

V. Pulse Width

Default value when parameter is On is 400 ms.

The default value for this parameter is set according to the permanently programmed settings for bradycardia

b,c

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V.

Table 42. Manual Defibrillation parameters

Parameter Selectable values

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 25; 26; 28; 30; 32;

35 J

Pathway

If the Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-

AX>B; B>AX

voltage delivery pathway. If the Active Can/SVC Coil parameter is set to SVC Off, the SVC Coil electrode is not used as part of the high-voltage delivery pathway.

Table 43. Manual Cardioversion parameters

Parameter Selectable values

Chamber Atrium; RV

Energy 0.4; 0.6 … 1.8; 2; 3 … 16; 18; 20; 22; 24; 25; 26; 28; 30; 32;

35 J

Pathway

AX>B; B>AX

Minimum R-R (atrial CV only) 400; 410 … 500 … 600 ms

Table 44. Shared manual ATP therapy parameters

Parameter Selectable values

Minimum Interval (atrial ATP) 100; 110; 120; 130 … 400 ms

Minimum Interval (ventricular ATP) 150; 160 … 200 … 400 ms

Amplitude 1; 2 … 6 ; 8 V

Pulse Width 0.10; 0.20 … 1.50 ms

VVI Backup (for atrial ATP therapy) On; Off

Pacing Rate 60; 70 … 120 bpm

V. Amplitude

V. Pulse Width

The default value for this parameter is set according to the permanently programmed settings for bradycardia

a,b

0.50; 0.75 … 5.00; 5.50; 6.00; 8.00 V

0.10; 0.20 … 1.50 ms

pacing.

Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V.

Table 45. Manual Ramp therapy parameters

Parameter Selectable values

Chamber Atrium; RV

RV Ramp therapy parameters

# Pulses 1; 2 … 6 … 15

%RR Interval 50; 53; 56; 59; 63; 66 … 84; 88; 91; 94; 97 %

Dec/Pulse 0; 10 ; 20; 30; 40 ms

Atrial Ramp therapy parameters

# Pulses 1; 2 … 6 … 15; 20; 30 … 100

%AA Interval 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88; 91; 94; 97 %

Dec/Pulse 0; 10 ; 20; 30; 40 ms

Table 46. Manual Burst therapy parameters

Parameter Selectable values

# Pulses 1; 2 … 8 … 15

%RR Interval 50; 53; 56; 59; 63; 66 … 84; 88 ; 91; 94; 97%

Table 47. Manual Ramp+ therapy parameters

Parameter Selectable values

# Pulses 1; 2; 3 … 15

R-S1 (%RR) 50; 53; 56; 59; 63; 66 … 75 … 84; 88; 91; 94; 97%

S1-S2 (%RR) 50; 53; 56; 59; 63; 66; 69 … 84; 88; 91; 94; 97%

S2-SN (%RR) 50; 53; 56; 59; 63; 66 … 84; 88; 91; 94; 97%

Table 48. Manual Burst+ therapy parameters

Parameter Selectable values

#S1 Pulses 1; 2 … 6 … 15; 20; 30 … 100

%AA Interval 28; 31; 34; 38; 41 … 59; 63; 66 … 84; 88; 91 ; 94; 97%

S1S2 Off; 28; 31; 34; 38; 41 … 59; 63; 66 … 84 ; 88; 91; 94;

97%

S2S3 Dec Off; 0; 10; 20 … 80 ms

Medtronic, Inc.

*M961655A001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636

Technical manuals

www.medtronic.com/manuals

Medtronic DDMC3D4 Implant Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

1 System overview

1.1 Introduction

1.2 System description

1.3 Indications and usage

1.4 MRI conditions for use

1.5 Contraindications

1.6 Pre-implant consideration

1.7 Feature summary

1.7.1 Programmer software features

1.7.2 Diagnostic data features

1.7.3 Pacing features

1.7.4 Tachyarrhythmia detection features

1.7.5 Tachyarrhythmia therapy features

1.7.6 Testing features

1.7.7 Additional operations

2 Warnings, precautions, and potential adverse events

2.1 General warnings and precautions

2.2 Explant and disposal

2.3 Handling and storage instructions

2.3.1 Device handling

2.3.2 Device storage

2.4 Lead evaluation and lead connection

2.5 Device operation

2.5.1 Pacemaker-dependent patients

2.6 Potential adverse events

3 Clinical data

3.1 Adverse events and clinical trial data

4 Implant procedure

4.1 Preparing for an implant

4.1.1 Instruments, components, and accessories required for an implant

4.1.2 Setting up the programmer and starting the application

4.1.3 Considerations for preparing for an implant

4.1.4 How to prepare the device for implant

4.2 Selecting and implanting the leads

4.2.1 Selecting the leads

4.2.2 How to verify lead and connector compatibility

Table 1. Lead and connector compatibility

4.2.3 Implanting the leads

4.3 Testing the lead system

4.3.1 Considerations for testing the lead system

4.3.2 How to verify and save the sensing and pacing values

Table 2. Acceptable sensing and pacing values

4.4 Connecting the leads to the device

Figure 1. Lead connector ports

4.4.1 How to connect a lead to the device

Figure 2. Inserting the torque wrench into the setscrew

Figure 3. Confirming the DF4-LLHH or DF4-LLHO lead connection

Figure 4. Confirming the IS-1 lead connection

4.5 Performing ventricular defibrillation threshold tests

4.5.1 High-voltage implant values

Table 3. High-voltage (HV) therapy values recommended at implant

4.5.2 How to prepare for defibrillation threshold testing

4.5.3 How to perform defibrillation threshold testing using T-Shock

4.5.4 How to perform defibrillation threshold testing using 50 Hz Burst

4.6 Positioning and securing the device

4.6.1 How to position and secure the device

Figure 5. Rotating the device to wrap the leads

Figure 6. Locating the suture holes

4.7 Completing the implant procedure

4.7.1 How to complete programming the device

4.7.2 How to assess the performance of the device and the leads

4.8 Replacing a device

4.8.1 How to explant and replace a device

5 Product specifications

5.1 Physical characteristics

Table 4. Physical characteristics

Figure 7. Connector ports and suture holes

5.2 Replacement indicators

Table 5. Replacement indicators

5.3 Projected service life

Projected service life in years

Table 7. Projected service life in years, with the Pacing Mode programmed to AAI<=>DDD

5.3.1 Projected service life considerations

5.4 Energy levels and typical charge times

Table 8. Maximum energy levels and typical full energy charge times