Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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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.
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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:
●
The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias.
●
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.
●
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.
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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:
●
The patient has no implanted lead extenders, lead adaptors, or abandoned leads.
●
The patient has no broken leads or leads with intermittent electrical contact, as confirmed by lead impedance
history.
●
The SureScan defibrillation system is implanted in the left or right pectoral region.
●
The SureScan device is operating within the projected service life.
●
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:
●
Continuous patient monitoring is required while MRI SureScan is programmed to On.
●
In the event that patient rescue is required, an external defibrillator must be immediately available.
Training requirements
●
A health professional who has completed cardiology SureScan training must be present during the
programming of the MRI SureScan feature.
●
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
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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
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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.
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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
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.
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.
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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.
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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:
●
To prevent the device from delivering unwanted shocks, interrogate the device and disable tachyarrhythmia
detection before explanting, cleaning, or shipping the device.
●
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.
●
Medtronic implantable devices are intended for single use only. Do not resterilize and reimplant explanted
devices.
●
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.
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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:
●
Cap abandoned leads to avoid transmitting electrical signals.
●
Plug any unused lead ports to protect the device.
●
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:
●
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.
●
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.
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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:
●
Keep external defibrillation equipment nearby for immediate use. Potentially harmful spontaneous or induced
tachyarrhythmias may occur during device testing.
●
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.
13
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
14
●
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)
15
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.
16
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.
17
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
1
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.
1
Your Medtronic representative can install the Model SW033 software application.
18
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,
19
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
a
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).
b
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.
20
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.
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).
22
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).
23
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.
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
MeasurementAcute or chronic leads
HV delivery pathway impedance20–200 Ω
Defibrillation threshold≤25 J
24
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.
25
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.
26
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.
27
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.
28
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
a
Mass78 g
H x W x D68 mm x 51 mm x 13 mm
Surface area of device can57 cm
Radiopaque ID
Medtronic radiopaque identifier
b
b
34 cm
PFZ
3
2
Materials in contact with human tissue
c
Titanium, polyurethane, silicone rubber
BatteryHybrid CFx lithium/silver vanadium oxide
a
Volume with connector ports unplugged.
b
The radiopaque ID, which includes a Medtronic-identifier symbol, can be viewed in a fluoroscopic image of the
device.
c
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.
29
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.
30
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
pacingPacing 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
pacingPacing 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
31
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 energy35 J
Maximum delivered energy
Maximum stored energy
Typical charge time at Beginning of Service (BOS)
Typical charge time at Recommended Replacement Time (RRT)
a
Energy delivered at connector block into a 50 Ω load.
b
For 35 J programmed energy, delivered energy exceeds 35 J.
c
Energy stored at charge end on capacitor.
d
Charge time during a nonwireless telemetry session may be slightly higher.
a,b
c
d
d
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.
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.
b
If the programmed RV Amplitude is 8 V, VVI pacing is delivered at 8 V with a pulse width of 1.2 ms.
a
B>AX
32; 35 J
a
b
b
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.
33
Table 10. Tachyarrhythmia detection parameters
ParameterProgrammable valuesShippedReset
AT/AF DetectionOn; MonitorMonitorMonitor
Zones1 ; 2——
AT/AF Interval (Rate)
a
150; 160 … 350 … 450 ms350 ms350 ms
Fast AT/AF Interval (Rate)a150; 160 … 200 … 250 ms——
VF Detection
VF Interval (Rate)
VF Initial Beats to Detect12/16; 18/24; 24/32; 30/40 ; 45/60;
uses this truncated interval value when applying the programmed criteria and calculating interval averages.
b
The AF/Afl, Sinus Tach, and Wavelet features are automatically set to On when VF Detection is set to On.
c
This setting applies to all sensing in this chamber for both tachyarrhythmia detection and bradycardia pacing
operations.
d
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.
Yes ; NoNoNo
if atrial lead position is
suspect? (Atrial Lead
Position Check)
Duration to stop12; 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 ChangeOn ; Off——
Time IntervalOff; 2; 4; 7 ; 12; 24; 36; 48 hr——
Shared A. ATP
A-A Minimum ATP Inter-
b
val
100; 110; 120; 130 … 400 ms150 ms150 ms
A. Pacing Amplitude1; 2 … 6 ; 8 V6 V6 V
A. Pacing Pulse Width0.1; 0.2 … 1.5 ms1.5 ms1.5 ms
VVI/VOO Backup PacingOff; On (Always); On (Auto Enable)——
VVI/VOO Backup Pacing
60; 70 … 120 bpm——
Rate
a
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.
b
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.
c
The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies.
It also applies to T-Shock inductions.
V-V Minimum ATP Interval150; 160 … 200 … 400 ms200 ms200 ms
V. Amplitude1; 2 … 6; 8 V8 V8 V
V. Pulse Width0.1; 0.2 … 1.5 ms1.5 ms1.5 ms
V. Pace Blanking150; 160 … 240 … 450 ms240 ms240 ms
Active Can/SVC Coil
Progressive Episode Thera-
c
Can+SVC On ; Can Off; SVC OffCan+SVC OnCan+SVC On
On; OffOffOff
pies
Confirmation+On ; OffOnOn
a
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.
b
Smart Mode is available only for Rx1– Rx4.
c
The Active Can/SVC Coil parameter applies to all automatic, manual, and emergency high-voltage therapies.
It also applies to T-Shock inductions.
V. Blank Post VP150; 160 … 200 … 450 ms200 ms240 ms
V. Blank Post VS120 ; 130 … 170 ms120 ms120 ms
a
When PVAB Method = Partial+ or Absolute
b
When PVAB Method = Partial
c
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
ParameterProgrammable valuesShippedReset
Upper Sensor Rate80; 85 … 120 … 175 bpm120 bpm—
ADL Rate60; 65 … 95 … 170 bpm95 bpm—
Rate Profile OptimizationOn ; OffOn—
ADL Response1; 2; 3 ; 4; 53—
Exertion Response1; 2; 3 ; 4; 53—
Activity ThresholdLow; Medium Low ; Medium High; HighMedium Low—
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 Active Can/SVC Coil parameter is set to Can Off, the Active Can electrode is not used as part of the high-
a
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.
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.
Table 44. Shared manual ATP therapy parameters
ParameterSelectable values
Minimum Interval (atrial ATP)100; 110; 120; 130 … 400 ms
Minimum Interval (ventricular ATP)150; 160 … 200 … 400 ms
Amplitude1; 2 … 6 ; 8 V
Pulse Width0.10; 0.20 … 1.50 ms
VVI Backup (for atrial ATP therapy)On; Off
Pacing Rate60; 70 … 120 bpm
V. Amplitude
V. Pulse Width
a
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
a
0.10; 0.20 … 1.50 ms
pacing.
b
Crosstalk may occur when atrial pacing amplitude is greater than 6.0 V.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636