Medtronic ATDRL1 Implant Manual

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Attesta™ L DR MRI SureScan™ ATDRL1

Dual chamber rate responsive pacemaker (DDDR)

Device Manual

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

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Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following list includes trademarks or registered trademarks of a Medtronic entity in the United States and/or in other countries.

Advisa DR MRI™, Advisa™, Attesta™, Capture Management™, EnPulse™, EnRhythm MRI™, EnRhythm™, GEM III™, GEM™, Kappa™, Marquis™, Medtronic AT500™, MVP™, Revo MRI™, Search AV™, SureScan™, TherapyGuide™

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1 System overview 4

1.1 Introduction 4

1.2 System description 4

2 Indications 5

3 Contraindications 5

4 MRI conditions for use 5

5 Warnings, precautions, and potential adverse events 6

5.1 Warnings and precautions to ensure intended device function 6

5.2 Potential adverse events 10

6 Patient selection and treatment 10

6.1 Select the pacing mode 10

6.2 Patient counseling information 11

6.3 Patient manual 11

6.4 Patient ID card 11

7 Clinical studies 11

7.1 Adverse events and clinical trial data 11

8 Implant procedure 12

8.1 Verify sufficient device longevity 12

8.2 Verify lead and connector compatibility 13

8.3 Test the lead system 14

8.4 Connect the leads to the device 14

8.5 Test the device operation 15

8.6 Position and secure the device 15

8.7 Program the device 16

8.8 Replace a device 16

9 Potential complications and emergency pacing 17

9.1 Potential complications 17

9.2 Emergency pacing 18

10 Magnet operation and Elective Replacement Indicator (ERI) 18

11 Device parameters 19

11.1 Shipping, nominal, and electrical reset parameters 19

11.2 Programmable parameters 24

11.3 Automatic and clinician-selectable diagnostics 30

11.4 Nonprogrammable parameters 32

12 Device information 33

12.1 Physical characteristics 33

12.2 Electrical specifications 34

12.3 Projected service life 35

12.4 Prolonged service period 36

12.5 Feature summary 37

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1 System overview

1.1 Introduction

About this manual – This document is primarily an implant manual. Regular patient follow-up sessions should be

scheduled after implant. Follow-up procedures such as monitoring battery measurements and confirming therapy parameters are described in the product documentation that is included with the software that supports this device. To obtain additional copies of product documentation, go to www.medtronic.com/manuals or contact a Medtronic representative.

This manual describes the Medtronic Attesta L DR MRI SureScan dual chamber, multiprogrammable, rate-responsive implantable pulse generator (IPG) bipolar/unipolar Model ATDRL1, also referred to as a pacemaker.

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

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

Programming guide – This manual contains device programming procedures and patient follow-up guidelines.

The programming guide applies to multiple models within a device family.

Reference manual – This manual contains feature descriptions, troubleshooting information, and other device reference information. The reference manual applies to multiple models within a device family.

Radio regulatory compliance information – This document provides compliance information related to the radio components of the device.

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.

1.2 System description

The Medtronic Attesta L DR MRI SureScan model ATDRL1 dual chamber implantable pulse generator (IPG) is a multi-programmable cardiac device that monitors and regulates the patient’s heart rate by providing single or dual chamber rate-responsive bradycardia pacing.

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, magnet mode, and all user-defined diagnostics. Before performing an MRI scan, refer to the MRI technical manual.

The users of this device include medical professionals (physicians, nurses, technicians, and their supporting staff) trained in surgery, cardiology, radiology, and magnetic resonance (MR) technology and able to implement the procedures documented in the instructions for use for this device.

Rate response – Rate response is controlled through an activity-based sensor.

Programmer and software – Use the appropriate Medtronic programmer and software to program this device.

Programmers from other manufacturers are not compatible with Medtronic devices but will not damage Medtronic devices.

Contents of sterile package – The package contains 1 implantable pulse generator and 1 torque wrench used to tighten setscrews.

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1.2.1 Usage environments

The device is intended to be used in the following environments and conditions:

• The device will be implanted in a properly equipped, staffed, and sterile surgical environment. Implant will take place under standard surgical protocols and in the patient population for which the device is indicated.

• Post-surgical patient and device follow-up care will take place in a properly equipped and staffed cardiology clinic or office.

• MRI procedures for patients with this device will take place in a properly equipped and staffed MR facility, and in consideration of the conditions and requirements described in Chapter 4, MRI conditions for use, page 5.

• After having an implant, patients may resume their lives at home, at work, and in other environments with consideration of the advice and restrictions documented in the Medical Procedure and EMI Warnings and Precautions Manual for Health Care Professionals and in the patient literature.

2 Indications

The Medtronic Attesta L DR MRI SureScan model ATDRL1 implantable pulse generator (IPG) is indicated for use in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity. This device is indicated for use in patients who have experienced one or more of the following conditions:

• symptomatic paroxysmal or permanent second- or third-degree AV block

• symptomatic bilateral bundle branch block

• symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders

• bradycardia-tachycardia syndrome

• vasovagal syndromes or hypersensitive carotid sinus syndromes

This device is also indicated for use in patients who may benefit from maintenance of AV synchrony through the use of dual chamber modes and atrial tracking modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony. Dual chamber modes are indicated for use in patients who have experienced one or both of the following conditions:

• various degrees of AV block

• VVI intolerance (for example, pacemaker syndrome) in the presence of a persistent sinus rhythm

3 Contraindications

The Medtronic Attesta L DR MRI SureScan model ATDRL1 implantable pulse generator (IPG) is contraindicated for the following applications:

• Dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias

• Asynchronous pacing in the presence or likelihood of competition between paced and intrinsic rhythms

• Use of implantable cardioverter defibrillators (ICD) with an IPG in unipolar configuration. Pacing in the unipolar configuration may cause the ICD either to provoke inappropriate therapy or to withhold appropriate therapy.

4 MRI conditions for use

A complete SureScan pacing system is required for use in the MR environment. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads. 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 the MRI SureScan mode to On. Scanning the patient without programming the MRI SureScan mode to On may result in patient harm or damage to the SureScan pacing system.

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

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 pacing system is implanted in the left or right pectoral region.

• The pace polarity parameters are set to Bipolar for programming the MRI SureScan mode to On.

• 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.

Notes:

• For radiology requirements, refer to the MRI technical manual.

• Before performing an MRI scan, refer to the MRI technical manual for MRI-specific warnings and

precautions.

Patient monitoring and rescue requirements

• Continuous patient monitoring is required during the MRI scan.

• 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.

5 Warnings, precautions, and potential adverse events

Before performing an MRI scan, refer to the Medtronic MRI technical manual for MRI-specific warnings and precautions.

5.1 Warnings and precautions to ensure intended device function

5.1.1 Device operation

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 does not program atrial outputs above 5.0 V or

1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program the Amplitude and Pulse Width. If a lead dislodges partially or completely, Atrial Capture Management may not prevent loss-of-capture.

Crosstalk – Crosstalk may cause the device to self-inhibit, which results in no pacing. Program Ventricular Safety Pacing to On to prevent inhibition due to crosstalk.

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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.

Effects of myopotential sensing in unipolar sensing configurations – In unipolar sensing configurations, the device may not distinguish myopotentials from cardiac signals. This may result in a loss of pacing due to inhibition. Also, unipolar atrial sensing in atrial tracking modes can result in elevated ventricular pacing rates. To address these situations, the device may be programmed to be less sensitive (using higher sensitivity values). However, the sensitivity level must be balanced against the potential to undersense true cardiac signals. Typically, this balance is easily attained for ventricular sensing using sensitivity values around 2.8 mV, but it may be difficult to attain for atrial sensing because of the smaller P-wave amplitudes.

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.

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 ppm. 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.

See Section 11.1, Shipping, nominal, and electrical reset parameters, page 19 for a complete list of preserved and changed partial and full reset parameters.

Epicardial leads – Epicardial leads have not been determined appropriate for use with the Ventricular Capture Management feature. Program Ventricular Capture Management to Off if implanting an epicardial lead. Note: Epicardial leads compromise the ability to safely perform an MRI scan on the MRI SureScan pacing system. Patients with epicardial leads are contraindicated for an MRI scan.

Extended Upper Tracking Rate – When programming Upper Tracking Rates of 190, 200, or 210 ppm, be careful to ensure that these rates are appropriate for the patient. The Upper Tracking Rates of 190, 200, and 210 ppm are intended primarily for use in pediatric patients.

False bipolar pathway with unipolar lead – When implanting a unipolar lead, ensure that the tip setscrew is properly engaged and that all electrical contacts are sealed to prevent electrical leakage. Electrical leakage may cause the device to inappropriately identify a unipolar lead as bipolar, resulting in loss of output.

Hex wrench – Do not use a blue-handled or right-angled hex wrench. These wrenches have torque capabilities greater than the lead connector can tolerate. The setscrews may be damaged by excessive torque.

Lead compatibility – Although Medtronic device connector modules conform to International Connector Standards, this device has not been tested for use with non-Medtronic leads. The known potential adverse consequences of using such a combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection.

Note: Bipolar or unipolar leads may be used with the Attesta L DR MRI SureScan model ATDRL1 device, but if leads other than bipolar MRI SureScan leads are used, the system is contraindicated for MRI scans.

Lead connection – Consider the following information when connecting the leads and 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.

Muscle stimulation – Muscle stimulation (for example, due to high-output unipolar pacing) may result in pacing at rates up to the Upper Sensor rate in rate responsive modes.

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Pacing and sensing safety margins – Consider lead maturation when selecting pacing amplitudes, pacing pulse widths, and sensing levels. Loss of capture may occur if lead maturation is not considered when selecting settings.

PMT intervention – Even with the feature turned to On, PMTs may still require clinical intervention such as pacemaker reprogramming, magnet application, drug therapy, or lead evaluation.

Rate-response modes – Rate response modes that are programmed above the programmed Lower Rate may not be tolerated by some patients.

Sensitivity setting – Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity threshold to its most sensitive setting of 0.18 mV. When susceptibility to interference is tested under the conditions specified in standards ISO 14708-2:2012 clause 27 and ISO 14117:2012, the device may sense the interference if the sensitivity threshold is programmed to any programmable sense threshold.

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

Tip contacts – When implanting a device, ensure that the tip setscrews are properly engaged and all electrical contacts are sealed to prevent possible electrical leakage. Also, ensure that electrical contacts are sealed when using lead extenders or adaptors. Electrical leakage may cause a loss of output. Note: Lead extenders or lead adaptors compromise the ability to safely perform an MRI scan on the SureScan pacing system. Patients with lead extenders or lead adaptors are contraindicated for an MRI scan.

Twiddler’s syndrome – Twiddler’s syndrome, i.e., patient manipulation of the device after implant, may cause the pacing rate to increase temporarily if the pacemaker is programmed to a rate responsive mode.

Ventricular Capture Management – Ventricular Capture Management does not program ventricular outputs above 5.0 V or 1.0 ms. If the patient needs a pacing output higher than 5.0 V or 1.0 ms, manually program Amplitude and Pulse Width. If a lead dislodges partially or completely, Ventricular Capture Management may not prevent loss-of-capture.

5.1.2 Device system warnings and precautions for pacemaker-dependent patients

Asynchronous pacing modes – Asynchronous pacing modes (DOO, VOO, AOO) disable sensing. It is not

appropriate to permanently program these pacing modes for pacemaker-dependent patients.

Diagnostic modes – Do not program diagnostic modes (ODO, OVO, and OAO) for pacemaker-dependent patients. These modes disable pacing. Instead, use the programmer’s inhibit function for brief interruption of outputs.

Inhibit function – Use caution when using the programmer to inhibit pacing. The patient is without pacing support when pacing is inhibited.

Polarity override – Do not override the polarity verification prompt with bipolar polarity when a unipolar lead is connected. Overriding the polarity verification prompt results in no pacing output.

Threshold Margin Test (TMT) and loss of capture – Be aware that loss of capture during a TMT at a 20% reduction in amplitude indicates an inadequate stimulation safety margin.

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.

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5.1.3 External devices during implant

External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use whenever

arrhythmias are possible or intentionally induced during device testing, implant procedures, or post-implant testing.

External pacing instrument – Keep an external pacing instrument available for immediate use. When the lead is disconnected, pacemaker-dependent patients are without pacing support.

5.1.4 Handling and storage instructions

Follow these guidelines when handling or storing the device.

Device storage – Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference. Exposing the device to magnets or electromagnetic interference may damage the device.

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).

Use by date – Do not implant the device after the “Use by” date on the package label. Battery longevity may be reduced.

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 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.

If the package information is damaged – If any information on the outer package or the sterile package is defaced or damaged so that you cannot read it, notify a Medtronic representative so that the device can be replaced.

If the printed manual is illegible – If this manual is supplied in its printed form and any part of it is illegible, contact a Medtronic representative to request a replacement manual.

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.

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.

For single use only – Do not resterilize and reimplant an explanted device that has been contaminated by contact with body fluids.

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.

5.1.5 Explant and disposal

Consider the following information related to device explant and disposal:

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

• 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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5.2 Potential adverse events

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

• Air embolism

• Allergic reaction

• Bleeding

• Body rejection phenomena including local tissue rejection

• Cardiac dissection

• Cardiac perforation

• Cardiac tamponade

• Chronic nerve damage

• Death

• Embolism

• Endocarditis

• Erosion of the device and lead through the skin

• Excessive fibrosis

• Extrusion

• Fibrillation or other arrhythmias

• Fluid accumulation

• Formation of cysts

• Heart block

• Heart wall rupture

• Hematoma/seroma

• Inappropriate acceleration of arrhythmias

• Infection

• Keloid formation

• Lead abrasion and discontinuity

• Lead migration/dislodgment

• Muscle and nerve stimulation

• Myocardial damage

• Myocardial irritability

• Myopotential sensing

• Pericardial effusion

• Pericardial rub

• Pneumothorax

• Threshold elevation

• Thromboemboli

• Thrombosis

• Tissue damage due to heating of device or lead (during an MRI procedure)

• Transvenous lead-related thrombosis

• Valve damage

• Venous occlusion

• Venous perforation

• Vein wall rupture

6 Patient selection and treatment

6.1 Select the pacing mode

TherapyGuide offers a simple, clinically focused method where the programmer suggests parameter values based on selected clinical conditions. Examples of clinical conditions include the condition of the sinus node and the quality of AV conduction. The rationale for suggested parameter values, including pacing mode, is based on clinical studies, literature, current practice, and the consensus of physicians.

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To navigate to the TherapyGuide Rationale window, perform the following steps:

1. Interrogate the pacemaker following implant.

2. Tap Params. The Parameters - Therapy screen displays.

3. Tap TherapyGuide > Rationale…. The Rationale window displays.

4. Tap Close twice to return to the Parameters - Therapy screen.

Note: Refer to the programming guide for detailed information on using TherapyGuide to inform your programming decisions.

6.2 Patient counseling information

The clinician may wish to discuss the following topics with the patient before discharge:

• Review the signs and symptoms that should be reported to the patient’s physician.

• Review instructions to the patient concerning physical activity.

• Advise the patient on the frequency of follow-up care.

• Inform the patient of cautions regarding sources of electromagnetic interference (EMI).

• Educate the patient about the consequences of device manipulation (Twiddler’s syndrome).

6.3 Patient manual

A patient manual is packaged with the device. The patient manual contains information for the patient, the patient’s family, and other interested people. Discuss the information in this manual with concerned individuals so they are familiar with the operation of the device. To obtain additional copies of the patient manual, contact a Medtronic representative, or call the toll-free phone number on the back cover of the patient manual.

6.4 Patient ID card

A temporary patient ID card is packaged with each device. A permanent patient ID card is mailed to the patient within a month after Medtronic receives the Device Registration Form. Advise the patient to always carry the patient ID card.

7 Clinical studies

7.1 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:

Advisa DR MRI system study – This clinical study, which evaluated the safety and efficacy of the Advisa DR MRI SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan feature. This study supports removal of the C1-T12 positioning restriction, so that any region of the body can be scanned when the MR Conditions for Use are followed.

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 Attesta L DR MRI SureScan model ATDRL1 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 Attesta L DR MRI SureScan model ATDRL1 devices. Note that the Ventricular Response Pacing (VRP) feature mentioned in the study is called Conducted AF Response in the Attesta L DR MRI SureScan model ATDRL1 devices.

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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.

EnRhythm clinical study – This clinical study, which evaluated the safety and efficacy of the EnRhythm model P1501DR devices, provides support for Managed Ventricular Pacing (MVP) in the Attesta L DR MRI SureScan model ATDRL1 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 Attesta L DR MRI SureScan model ATDRL1 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 Attesta L DR MRI SureScan model ATDRL1 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).

Revo MRI SureScan pacing system clinical study – This clinical study, which evaluated the safety and efficacy of the EnRhythm MRI SureScan pacing system in the clinical magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan feature. This study was conducted with the C1 – T12 MRI scan exclusion zone in place.

SureScan Pacing System Post-Approval Study – This clinical study, which evaluated safety and performance of approved systems in a magnetic resonance imaging (MRI) environment, provides support for the MRI SureScan feature.

8 Implant procedure

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

For information about replacing previously implanted devices, see Section 8.8, Replace a device, page 16

8.1 Verify sufficient device longevity

Complete the following steps prior to opening the pacemaker box:

1. Check the use-by date printed on the package.

2. Place the programmer head over the box and start the application.

3. Interrogate the device.

4. Confirm the battery voltage is at least 2.75 V at room temperature using the Programming Guide instructions for viewing battery status.

5. Contact your Medtronic representative if the use-by date or battery voltage is out of range.

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8.2 Verify lead and connector compatibility

Ø 1.93 mm (2x)

Ø 3.5 mm (2x)

19.1 mm (2x)

25.2 mm (2x)

A complete SureScan pacing system is required for use in the MR environment. A complete SureScan pacing system includes a SureScan device with Medtronic SureScan leads. 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: Verify lead and connector compatibility before using a lead with this device. Using an incompatible lead may damage the connector, result in electrical current leakage, or result in an intermittent electrical connection.

A lead adaptor may be needed to connect the lead to the device. Contact a Medtronic representative for questions about lead adaptor compatibility.

Note: Lead adaptors compromise the ability to safely scan the SureScan pacing system during an MRI scan. Patients with lead adaptors are contraindicated for an MRI scan.

Select a compatible lead. Refer to the following table.

Table 1. Lead and connector compatibility

Connector port Primary leads

A, V IS-1a bipolar and IS-1 unipolar

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

8.2.1 Connector dimensions

The following figure provides connector dimensions for the Attesta L DR MRI SureScan model ATDRL1 device.

Figure 1. Attesta L DR MRI SureScan model ATDRL1 connector dimensions

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8.3 Test the lead system

For lead testing procedures, refer to the technical manual supplied with the implant support instrument.

8.4 Connect the leads to the device

Warning: Verify that the lead connections are secure. Loose lead connections may result in inappropriate sensing,

which can cause inappropriate arrhythmia therapy or a failure to deliver arrhythmia therapy.

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

Connect the leads to the device by performing the following steps:

1. Insert the wrench into a grommet on the connector port.

a. Check that the setscrew is retracted from the connector port. If the connector port is obstructed, retract

the setscrew to clear it. Do not disengage the setscrew from the connector block, see Figure 2.

Figure 2. Preparing the connector port setscrew

1 IS-1 connector port, A 2 IS-1 connector port, V

b. Leave the wrench in the grommet until the lead is secure. This allows a pathway for venting trapped air

when the lead is inserted, see Figure 3.

Figure 3. Wrench in the grommet

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2. Push the lead connector pin into the connector port until the connector pin is visible in the lead viewing area. Sterile water may be used as a lubricant. Sealant is not required.

Figure 4. Inserting a lead into the device

1 Model ATDRL1 IS-1 leads — The lead pins are visible at the end of the viewing area.

3. Tighten the setscrew by turning the wrench to the right until the wrench clicks.

4. Repeat these steps for each lead.

5. Gently pull on the lead to confirm the connection.

8.5 Test the device operation

Warning: Keep an external pacing instrument available for immediate use. When the leads are disconnected,

pacemaker-dependent patients are without pacing support.

Verify device operation by reviewing an ECG. If pacing and sensing are not adequate, perform one or more of the following tasks for one or both leads, as needed:

• Verify that the pacing threshold margin is adequate at the time of implant (and at each patient follow-up session).

• Verify the connection of the lead to the device. Confirm that the lead connector pin appears in the viewing area.

• Disconnect the lead from the device. Visually inspect the lead connector and lead. Replace the lead if necessary.

• Retest the lead. Inadequate electrical signals may indicate lead dislodgment. If necessary, reposition or replace the lead.

8.6 Position and secure the device

Note: Proper device placement can facilitate lead wrap and prevent muscle stimulation and device migration. The

device may be implanted in right or left pectoral sites. Either side of the device may face the skin to facilitate excess lead wrap.

Note: Implant the device within 5 cm (2 in) of the surface of the skin to optimize post-implant ambulatory monitoring.

1. Verify that each lead connector pin or plug 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. Do not kink the lead body.

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

4. Suture the device securely within the pocket. Use non-absorbable sutures. Secure the device to minimize post-implant rotation and migration. Use a surgical needle to penetrate the suture hole on the device.

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Figure 5. Location of suture hole

1 Suture hole

5. Suture the pocket incision closed.

8.7 Program the device

1. If unipolar leads are implanted, you may want to manually complete the Implant Detection process.

a. Tap Params. b. Program the Pace Polarity and Sense Polarity parameters to Unipolar.

Note: If the patient experiences muscle stimulation while being paced in the unipolar configuration, reduce the amplitude or narrow the pulse width. Maintain adequate stimulation safety margins.

c. Tap Additional Features… and program the Implant Detection parameter to Off/Complete.

2. Verify that the pacing and detection parameters are programmed to values that are appropriate for the patient.

3. Enter the patient’s information in the Patient Information screen. Note: Use the Patient Information screen to document complete information about the implanted leads and other hardware implanted in the patient, including abandoned devices, leads, 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 programming guide.

8.8 Replace a device

To retain the ability to safely scan the SureScan pacing system during MRI scans, the MRI conditions for use in Chapter 4, MRI conditions for use, page 5 must be followed. Refer to the Medtronic MRI technical manual for additional information.

Warning: Bipolar or unipolar leads may be used with the Attesta L DR MRI SureScan model ATDRL1 device, but if leads other than bipolar SureScan leads are used, the system is not approved for MRI scans. Before performing an MRI scan, refer to the Medtronic MRI technical manual for additional information.

Warning: Abandoned leads or previously implanted non-MRI labeled leads compromise the ability to safely scan the SureScan pacing system during future MRI scans. When implanting a SureScan pacing system, consider the risks associated with removing previously implanted leads before removing the leads to maintain the ability to safely scan the SureScan pacing system. Refer to the Medtronic MRI technical manual for additional information.

Warning: Keep an external pacing instrument available for immediate use. When the leads are disconnected, pacemaker-dependent patients are without pacing support.

Note: Any unused leads that remain implanted must be capped with a lead pin cap to avoid transmitting electrical signals. 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. Contact your Medtronic representative for information about lead pin caps.

Page 17

8.8.1 How to explant and replace a device

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

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

3. Use a torque wrench to loosen the setscrews in the connector port.

4. Gently pull the leads out of the connector port.

5. Evaluate the condition of the leads (see Section 8.3, Test the lead system, page 14). Replace the leads 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.

6. Connect the leads to the replacement device (see Section 8.4, Connect the leads to the device, page 14).

Note: Lead adaptors may be needed to connect the leads to the replacement device (see Section 8.2, Verify lead and connector compatibility, page 13). Contact a Medtronic representative for questions about

compatible lead adaptors. Note: Lead adaptors compromise the ability to safely perform an MRI scan on the SureScan pacing system in the future. Patients with lead adaptors are contraindicated for an MRI scan.

7. Use the replacement device to evaluate stimulation thresholds and sensing potentials.

8. After confirming acceptable electrical measurements, place the device in the surgical pocket and suture the pocket incision closed.

9. 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.

9 Potential complications and emergency pacing

9.1 Potential complications

The pacemaker/lead system may operate inappropriately or fail completely due to several potential complications. Note the following potential complications.

• Pacing thresholds can change over time. Clinicians are advised to program a pacing threshold margin that will prevent loss of capture in case of an increase in pacing threshold.

• Potential effects of premature battery depletion are decreased output voltage, no pacing output, loss-of-capture, Recommended Replacement Time (RRT), Elective Replacement Indicator (ERI), and eventual erratic pacing.

• Potential effects of pacemaker component(s) failure are loss of pacing output, pacing rate and other parameter changes, reversion to asynchronous mode, loss-of-capture, loss of programming capability, Recommended Replacement Time (RRT), Elective Replacement Indicator (ERI), and erratic pacing.

• Potential effects of the activity sensor detecting muscle or mechanical stimulation may increase the pacing rate to levels higher than expected for a given patient activity. In addition, an open or shorted activity sensor may cause rate response pacing to cease operating.

• Potential effects of electromagnetic interference (EMI) on the pacemaker’s circuitry are pacing output inhibition, reversion to asynchronous mode, pacing synchronized to the EMI source, and a partial or full electrical reset condition.

• Electromagnetic interference (EMI) from electrocautery and defibrillation may cause any of the following conditions: – pacing output inhibition – temporary pause in pacing – permanent loss of pacing output – reversion to asynchronous mode – pacing synchronized to the EMI source – Recommended Replacement Time (RRT) – Elective Replacement Indicator (ERI) – partial or full electrical reset

Page 18

• Potential effects of poor connection of lead to pacemaker connector block are intermittent or continuous loss-of-capture, failure to sense properly or loss of sensing, crosstalk between leads, and inhibition of pacing.

• Reversed connection of the atrial and ventricular leads will result in improper pacing and sensing operations.

• Potential effects of displaced or fractured lead are intermittent or continuous loss-of-capture and/or sensing, and inhibition of pacing. Cardiac perforation may cause intermittent or continuous loss-of-capture and/or sensing, inhibition of pacing, cardiac tamponade, and muscle or nerve stimulation. Myocardial irritability at the time of lead insertion may cause fibrillation or flutter. Elevation of pacing thresholds may cause a loss-of-capture.

9.2 Emergency pacing

Emergency pacing provides VVI pacing at high output settings in emergency situations for pacemaker-dependent patients. Table 2 lists the emergency settings.

Table 2. Emergency settings

Parameter Setting

Mode VVI

Pacing Rate 70 ppm

Ventricular

Amplitude 7.5 V

Pulse Width 1.5 ms

Sensitivity 2.8 mV

Pacing Polarity Unipolar

Sensing Polarity Unipolar

Lead Monitor Monitor Only

Ventricular Refractory Period 330 ms

Single Chamber Hysteresis Off

Capture Management Off

10 Magnet operation and Elective Replacement Indicator (ERI)

Table 3. Magnet operation and Elective Replacement Indicator (ERI) status

Magnet operation Indicators of ERI status

Without magnet With magnet Without magnet With magnet

DDDR/DDD DOO at 85 ppm VVI at 65 ppm VOO at 65 ppm

VDD VOO at 85 ppm VVI at 65 ppm VOO at 65 ppm

VVI/AAI VOO/AOO at 85 ppm VVI at 65 ppm VOO at 65 ppm

Note: For the purpose of determining Magnet Modes, the AAI<=>DDD and AAIR<=>DDDR modes are considered dual chamber modes.

Page 19

Note: The device does not respond to the application of a magnet for one hour after the use of a programmer unless the session is ended with the command option to immediately clear data collected in the device. The default command for ending a session allows the device to retain collected data for one hour.

11 Device parameters

11.1 Shipping, nominal, and electrical reset parameters

Notes:

• “Unchanged” indicates that the programmed setting is unaffected by nominal programming or an electrical reset event. “Adaptive” indicates that the parameter is adapted during operation.

• The shipping parameters for some features are not applied until the 30-minute Implant Detection period is complete.

• After certain serious device errors, the pacemaker will recover as a Model SES01. If this occurs, contact a Medtronic representative.

Table 4. Mode and rates

Partial electri-

Parameter Shipping Medtronic nominal

Mode and rates

Mode AAIR <=> DDDR AAIR <=> DDDR Unchanged VVI

Mode Switch On On Unchanged Off

Detect Rate 175 bpm 175 bpm 175 bpm 175 bpm

Detect Duration No Delay No Delay No Delay No Delay

Blanked Flutter Search

Lower Rate 60 ppm 60 ppm Unchanged 65 ppm

Upper Tracking Rate 130 ppm 130 ppm Unchanged 120 ppm

Upper Sensor Rate 130 ppm 130 ppm Unchanged 120 ppm

Table 5. Rate Response

Parameter Shipping

ADL Rate 95 ppm 95 ppm Unchanged 95 ppm

Rate Profile Optimization On On Unchanged Off

ADL Response 3 3 3 3

Exertion Response 3 3 3 3

ADL Setpoint 15 Unchanged 15 15

UR Setpoint 40 Unchanged 40 40

Activity Threshold Medium/Low Unchanged Medium/Low Medium/Low

Acceleration 30 s Unchanged 30 s 30 s

Deceleration Exercise Unchanged Exercise Exercise

On On Unchanged On

Medtronic nominal

cal reset

Partial electrical reset

Full electrical reset

Page 20

Table 6. Atrial Lead

Parameter Shipping

Amplitude

3.5 V (Adaptive)

Pulse Width 0.4 ms

(Adaptive)

Sensitivity 0.5 mV

(Adaptive)

Medtronic nominal

3.5 V (Adaptiveb)

0.4 ms (Adaptiveb)

0.5 mV (Adaptiveb)

Partial electrical reset

Full electrical reset

Unchanged 5.0 V

Unchanged 0.4 ms

Unchanged 0.5 mV

Sensing Assurance On On Unchanged Off

Pacing Polarity Configure Unchanged Unchanged Configure

Sensing Polarity Configure Unchanged Unchanged Configure

Lead Monitor Configure Unchanged Unchanged Configure

Notify if < 200 Ω 200 Ω 200 Ω 200 Ω

Notify if > 4000 Ω 4000 Ω 4000 Ω 4000 Ω

Monitor Sensitivity 8 8 8 8

Amplitude is determined 200 µs after the leading edge of the pace.

Value from which adaptive adjustment begins when nominals are programmed.

Bipolar model reverts to Implant Detection during which polarity is automatically configured.

Table 7. Ventricular lead

Parameter Shipping

Amplitude

3.5 V (Adaptive)

Pulse Width 0.4 ms

(Adaptive)

Sensitivity 2.8 mV

(Adaptive)

Medtronic nominal

3.5 V (Adaptiveb)

0.4 ms (Adaptiveb)

2.8 mV (Adaptiveb)

Partial electrical reset Full electrical reset

Unchanged 5.0 V

Unchanged 0.4 ms

Unchanged 2.8 mV

Sensing Assurance On On Unchanged Off

Pacing Polarity Configure Unchanged Unchanged Configure

Sensing Polarity Configure Unchanged Unchanged Configure

Lead Monitor Configure Unchanged Unchanged Configure

Notify if < 200 Ω 200 Ω 200 Ω 200 Ω

Notify if > 4000 Ω 4000 Ω 4000 Ω 4000 Ω

Monitor Sensitivity 8 8 8 8

Amplitude is determined 200 µs after the leading edge of the pace.

Value from which adaptive adjustment begins when nominals are programmed.

Bipolar model reverts to Implant Detection during which polarity is automatically configured.

Page 21

Table 8. Atrial Capture Management

Parameter Shipping

Atrial Capture Manage-

Adaptive Adaptive Unchanged Off

Medtronic nominal

Partial electrical reset Full electrical reset

ment

Amplitude Margin 2x (times) 2x (times) Unchanged 2x (times)

Minimum Adapted

1.5 V 1.5 V Unchanged 1.5 V

Amplitude

Capture Test Fre-

Day at… Day at… Day at… Day at…

quency

Capture Test Time 1:00:00 AM 1:00:00 AM 1:00:00 AM 1:00:00 AM

Acute Phase Days

112 days Unchanged Unchanged 112 days

Remaining

Table 9. Ventricular Capture Management

Parameter Shipping

Ventricular Capture

Adaptive Adaptive Unchanged Off

Medtronic nominal

Partial electrical reset Full electrical reset

Management

Amplitude Margin 2x (times) 2x (times) Unchanged 2x (times)

Minimum Adapted

2.0 V 2.0 V Unchanged 2.0 V

Amplitude

Capture Test Fre-

Day at Rest Day at Rest Day at Rest

Day at Rest

quency

Capture Test Time None None None

Acute Phase Days

112 days Unchanged 112 days 112 days

None

Remaining

Sensing During Search Adaptive Adaptive Adaptive Adaptive

If values differ from nominal, the Capture Test Time will be set to occur every Day at… 12 hours after electrical reset time.

Table 10.

Parameter Shipping

Paced AV (PAV) 150 ms 150 ms

Sensed AV (SAV) 120 ms 120 ms

Intrinsic Activation and AV Intervals

Medtronic nominal

Partial electrical reset

150 ms

120 ms

Full electrical reset

150 ms

120 ms

RAAV Off Off Unchanged Off

Start Rate 80 ppm 80 ppm 80 ppm 80 ppm

Stop Rate 120 ppm 120 ppm 120 ppm 120 ppm

Maximum Offset -40 ms -40 ms -40 ms -40 ms

Page 22

Table 10. Intrinsic Activation and AV Intervals (continued)

Parameter Shipping

Medtronic nominal

Partial electrical reset

Search AV+ On On Unchanged Off

Max Increase to AV 170 ms 170 ms Unchanged 110 ms

Sinus Preference On On Unchanged Off

Sinus Preference

10 ppm 10 ppm 10 ppm 10 ppm

Zone

Search Interval 10 min 10 min 10 min 10 min

Value from which adaptive adjustment begins when nominals are programmed.

Reset value from which adaptive adjustment begins if Search AV+ is On at a partial reset.

Table 11. Refractory/Blanking

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

PVARP Auto Auto Unchanged 310 ms

Minimum PVARP 250 ms 250 ms Unchanged None

PVAB 180 ms 180 ms 180 ms 180 ms

Atrial Refractory

Period

Atrial Blanking Period

Ventricular Refractory

— 250 ms Unchanged 310 ms

— 180 ms 180 ms 180 ms

230 ms 230 ms 230 ms 230 ms

Period

Ventricular Blanking

28 ms 28 ms 28 ms 28 ms Period (after atrial pace) (PAVB)

Sensor varied PVARP and automatic PVARP are disabled at full electrical reset.

Atrial modes only.

Full electrical reset

Table 12. Additional features

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

Sleep Function Off Off Off Off

Sleep Rate 50 ppm 50 ppm 50 ppm 50 ppm

Bed Time 10:00:00 PM 10:00:00 PM 10:00:00 PM 10:00:00 PM

Wake Time 8:00:00 AM 8:00:00 AM 8:00:00 AM 8:00:00 AM

Non-Competitive Atrial

On On Unchanged Off Pacing

Single Chamber Hyste-

Off Unchanged Unchanged Off resis

Rate Drop Response

Detection Type Off Off Unchanged Off

Page 23

Table 12. Additional features (continued)

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

Intervention Rate 100 ppm 100 ppm Unchanged 100 ppm

Intervention Duration 2 min 2 min Unchanged 2 min

Detection Beats 2 beats 2 beats 2 beats 2 beats

Drop Rate 50 ppm 50 ppm Unchanged 50 ppm

Drop Size 25 bpm 25 bpm 25 bpm 25 bpm

Detection Window 25 s 25 s 25 s 25 s

PMT Intervention Off Off Unchanged Off

PVC Response On On Unchanged On

Ventricular Safety Pac-

On On Unchanged On ing

Implant Detection On/Restart Unchanged Unchanged On/Restart

Table 13. Interventions

Parameter Shipping

Post Mode Switch

Off Off Unchanged Off

Medtronic nominal

Partial electrical reset Full electrical reset

Overdrive

Overdrive Period 10 min 10 min Unchanged 10 min

Overdrive Rate 80 ppm 80 ppm Unchanged 80 ppm

Atrial Preference Pac-

Off Off Unchanged Off ing

Maximum Rate 100 ppm 100 ppm 100 ppm 100 ppm

Interval Decrement 30 ms 30 ms 30 ms 30 ms

Search Beats 20 20 20 20

Conducted AF

Off Off Unchanged Off Response

Maximum Rate 110 bpm 110 bpm 110 bpm 110 bpm

Table 14. MRI SureScan

Medtronic

Parameter Shipping

nominal

MRI SureScan Off Off Off

The MRI SureScan parameter cannot be programmed until the reset has been cleared.

Partial electrical reset Full electrical reset

Off

Page 24

Table 15. Telemetry Features

Parameter Shipping

Transtelephonic Moni-

Off Unchanged Unchanged Off

Medtronic nominal

Partial electrical reset Full electrical reset

tor

Extended Telemetry Off Unchanged Off Off

Extended Marker Standard Unchanged Standard Standard

11.2 Programmable parameters

Caution: Do not program device parameters before implant.

11.2.1 Pacing parameters

Caution: Do not program Rate Response until after Implant Detection is complete.

Caution: When programming Upper Tracking Rates of 190, 200, or 210 ppm, be careful to ensure that these rates

are appropriate for the patient. The Upper Tracking Rates of 190, 200, and 210 ppm are intended primarily for use in pediatric patients.

Note: In the event of a component failure, the limits for atrial and ventricular rates are held independently to an upper rate limit. This rate limit is automatically disabled with high rate temporary modes. If the Upper Tracking Rate is set to 190 ppm or higher, the atrial and ventricular Rate Limit is 227 ppm. Otherwise, the atrial and ventricular Rate Limit is 200 ppm.

Table 16. Mode and rates

Parameter Settings Notes

Mode AAIR <=> DDDR; AAI <=> DDD; DDDR;

DDD; DDIR; DDI; DVIR; DVI; DOOR; DOO; VDD; VVIR; VDIR; VVI; VDI; VVT; VOOR; VOO; AAIR; ADIR; AAI; ADI; AAT; AOOR; AOO; ODO; OVO; OAO

Mode Switch On; Off

Detect Rate 120; 125; 130 … 200; 210; 220 bpm

Detect Duration No Delay; 10; 20 … 60 s

Blanked Flutter Search On; Off

Lower Rate

30; 35; 40 … 170 ppm (except 65 and 85 ppm)

Upper Tracking Rate 80; 90; 95 … 180 ppm

190; 200; 210 ppm

Upper Sensor Rate 80; 90; 95; 100 … 180 ppm

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

Page 25

Table 17. Rate Response

Parameter Settings Notes

ADL Rate 60; 65; 70 … 175 ppm

Rate Profile Optimiza-

On; Off

tion

ADL Response 1; 2; 3; 4; 5

Exertion Response 1; 2; 3; 4; 5

ADL Setpoint 5; 6; 7 … 40; 42; 44; 46 … 80 Programmable from the Exercise test only

UR Setpoint 15; 16; 17 … 40; 42; 44; 46 … 80; 85;

Programmable from the Exercise test only

90; 95 … 180

Activity Threshold Low; Medium/Low; Medium/High;

High

Acceleration 15 s; 30 s; 60 s

Deceleration 2.5 min; 5 min; 10 min; Exercise

Table 18. Atrial Lead

Parameter Settings Notes

Amplitudea (with Atrial Capture Management)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0 V 0.625, 0.875, 1.125, 1.375, 1.625, and

1.875 V can be set by Capture Management. Values are displayed but are not selectable.

Amplitudea (without Atrial Capture Management)

Pulse Width (with Atrial Capture Management)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0; 5.5;

6.0; 7.5 V

0.12; 0.15; 0.21; 0.27; 0.34; 0.40;

0.46; 0.52; 0.64; 0.76; 1.00 ms

Settings lower than 0.40 ms can be programmed, but Capture Management adjusts them to 0.40 ms.

Pulse Width (without Atrial Capture Management)

0.12; 0.15; 0.21; 0.27; 0.34; 0.40;

0.46; 0.52; 0.64; 0.76; 1.00; 1.25;

1.50 ms

Sensitivity 0.18; 0.25; 0.35 mV

0.5; 0.7; 1.0; 1.4; 2.0; 2.8; 4.0 mV

0.18, 0.25, and 0.35 mV apply to bipolar atrial sensing only.

Sensing Assurance On; Off

Pacing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not

selectable.

Sensing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not

selectable.

Lead Monitor Configure; Monitor Only; Adap-

tive; Off

Notify if < (less than) 200 Ω Non-programmable.

Notify if > (greater than) 1000; 2000; 3000; 4000 Ω

Monitor Sensitivity 2; 3; 4 … 16

Amplitude is determined 200 µs after the leading edge of the pace.

Page 26

Table 19. Atrial Capture Management

Parameter Settings Notes

Atrial Capture Manage-

Off; Monitor Only; Adaptive

ment

Amplitude Margin 1.5x; 2x; 2.5x; 3x; 4x (times)

Minimum Adapted

0.5; 0.75; 1.0 … 3.5 V

Amplitude

Capture Test Frequency

Capture Test Time 12:00:00 AM; 1:00:00 AM …

1; 2; 4; 8; 12 hours; Day at rest; Day at… ; 7 Days at…

For Day(s) at…, next parameter specifies the time of day.

Applies only for Day(s) at… parameter.

11:00:00 PM

Acute Phase Days Remaining

If the acute phase is completed, the time and date of completion are indicated below Acute Phase Days

Off; 7; 14 … 84; 112; 140; 168; 196; 224; 252 days

Remaining.

Table 20. Ventricular Lead

Parameter Settings Notes

Amplitudea (with Ventricular Capture Management)

0.5; 0.75; 1.0 … 4.0; 4.5; 5.0 V 0.625, 0.875, 1.125, 1.375, 1.625, and

1.875 V can be set by Ventricular Capture Management. Values are displayed but are not selectable.

Amplitudea (without Ventricular Capture Man-

0.5; 0.75; 1.0… 4.0; 4.5; 5.0; 5.5; 6.0;

7.5 V

agement)

Pulse Width (with Ventricular Capture Management)

Pulse Width (without Ventricular Capture Management)

0.12; 0.15; 0.21; 0.27; 0.34; 0.40;

0.46; 0.52; 0.64; 0.76; 1.00 ms

0.12; 0.15; 0.21; 0.27; 0.34; 0.40;

0.46; 0.52; 0.64; 0.76; 1.00; 1.25;

1.50 ms

Settings lower than 0.40 ms can be programmed, but Capture Management adjusts them to 0.40 ms.

Sensitivity 1.0; 1.4; 2.0; 2.8; 4.0; 5.6; 8.0;

11.2 mV

Sensing Assurance On; Off

Pacing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.

Sensing Polarity Bipolar; Unipolar; Configure Configure is displayed but is not selecta-

ble.

Lead Monitor Configure; Monitor Only; Adaptive;

Off

Notify if < (less than) 200 Ω Non-programmable.

Notify if > (greater than) 1000; 2000; 3000; 4000 Ω

Monitor Sensitivity 2; 3; 4 … 16

Amplitude is determined 200 µs after the leading edge of the pace.

Page 27

Table 21. Ventricular Capture Management

Parameter Settings Notes

Ventricular Capture

Off; Monitor Only; Adaptive

Management

Amplitude Margin 1.5x; 2x; 2.5x; 3x; 4x (times)

Minimum Adapted

0.5; 0.75; 1.0 … 3.5 V

Amplitude

Capture Test Frequency

15 min; 30 min; 1 hour; 2 hours; 4 hours; 8 hours; 12 hours; Day at rest;

For Day(s) at …, next parameter specifies the time of day.

Day at…; 7 Days at…

Capture Test Time 12:00:00 AM; 1:00:00 AM …

Applies only for Day(s) at … parameter.

11:00:00 PM

Acute Phase Days Remaining

Off; 7; 14 … 84; 112; 140; 168; 196; 224; 252 days

Sensing During Search Unipolar; Bipolar; Adaptive

If the acute phase is completed, the Acute Phase Completed time and date are indicated below Acute Phase Days Remaining.

Table 22. Intrinsic Activation and AV Intervals

Parameter Settings Notes

Paced AV (PAV) 30; 40; 50 … 350 ms

Sensed AV (SAV) 30; 40; 50 … 350 ms

RAAV On; Off

Start Rate 50; 55; 60 … 175 ppm

Stop Rate 55; 60; 65 … 180 ppm

Maximum Offset -10; -20; -30 … -300 ms

Search AV+ On; Off

Max Increase to AV 10; 20; 30 … 250 ms

Sinus Preference On; Off

Sinus Preference Zone 3; 5; 10; 15; 20 ppm

Search Interval 5; 10; 20; 30 min

Table 23. Refractory/Blanking

Parameter Settings Notes

PVARP Auto; Varied; 150; 160; 170 …

500 ms

Minimum PVARP 150; 160; 170 … 500 ms Auto PVARP only.

PVAB 130; 140; 150 … 350 ms Blanking for PVARP.

Ventricular Refractory

150; 160; 170 … 500 ms

Period

Page 28

Table 23. Refractory/Blanking (continued)

Parameter Settings Notes

Atrial Refractory Perioda180; 190; 200 … 500 ms

Ventricular Blanking

20; 28; 36; 44 ms After atrial pace.

Period

Atrial Blanking Period

Atrial modes only.

130; 140; 150 … 350 ms

Table 24. Temporary parameters

Parameter Settings Notes

Chamber Atrium; Ventricle Setting determines available modes.

Mode DDD; DDI; DOO; VDD; VDI; VVI;

VVT; VOO; AAI; ADI; AAT; AOO;

Availability of modes is dependent on programmed mode.

ODO; OVO; OAO

Lower Rate 30; 35; 40 … 180

(except 65 and 85 ppm)

Rates above 180 ppm are available by

selecting the enable button. 190; 200; 210 … 250; 260; 270; 280; 300; 310; 320; 330; 350; 370; 380; 400 ppm

Amplitude

0.25; 0.375 … 2.0; 2.25; 2.50;

2.75 … 4.0; 4.5; 5.0; 5.5; 6.0; 7.5 V

Pulse Width 0.03; 0.06; 0.09 … 0.15; 0.21; 0.27;

0.34; 0.40; 0.46; 0.52; 0.64; 0.76;

1.00; 1.25; 1.50 ms

Atrial Sensitivity 0.18; 0.25; 0.35 mV

0.5; 0.7; 1.0; 1.4; 2.0; 2.8; 4.0 mV

Ventricular Sensitivity 1.0; 1.4; 2.0; 2.8; 4.0; 5.6; 8.0;

11.2 mV

AV Delay 30; 40; 50 … 350 ms Selection sets PAV and SAV if pertinent to

mode.

The amplitude values in 0.125 V increments apply only to the Capture Management and Temporary test.

11.2.2 Additional features

Table 25.

Additional rate therapies

Parameter Settings Notes

Sleep Function On; Off

Sleep Rate 30; 35; 40 … 90 ppm

(except 65 and 85 ppm)

Bed Time 12:00:00 AM; 12:15:00 AM;

12:30:00 AM … 11:45:00 PM

Wake Time 12:00:00 AM; 12:15:00 AM;

12:30:00 AM … 11:45:00 PM

Page 29

Table 25. Additional rate therapies (continued)

Parameter Settings Notes

Non-Competitive Atrial

On; Off

Pacing

Single Chamber Hyste-

Off; 40; 50; 60 ppm

resis

Rate Drop Response

Detection Type Off; Low Rate; Drop; Both

Intervention Rate 60; 70; 75 … 180 ppm (except 65 and

85 ppm)

Intervention Duration 1; 2; 3 … 15 min

Detection Beats 1; 2; 3 beats

Drop Rate 30; 40; 50 … 100 ppm

Drop Size 10; 15; 20 … 50 bpm

Detection Window 10; 15; 20 … 30 s

1; 1.5; 2; 2.5 min

Table 26. MRI SureScan parameters

Parameter Settings Notes

MRI SureScan On; Off

MRI Pacing Mode DOO; AOO; VOO; ODO

MRI Pacing Rate 60; 70; 75; 80; 90; 95 … 120 bpm

Table 27. Additional refractory/blanking features

Parameter Settings Notes

PMT Intervention On; Off

PVC Response On; Off

Ventricular Safety Pac-

On; Off

ing

Table 28. Telemetry Features

Parameter Settings Notes

Transtelephonic Monitor On; Off

Extended Telemetry On; Off

Extended Marker

Therapy Trace markers cannot be displayed or printed on the programmer.

Standard; Therapy Trace

Page 30

Table 29. Implant detection

Parameter Settings Notes

Implant Detection On/Restart; Off/Complete If Implant Detection is completed, the time

and date of completion are indicated below the Off/Complete setting.

Table 30. Status (reset) parameters

Parameter Settings Notes

Atrial Lead Status Reset Indicator

Ventricular Lead Status Reset Indicator

RRT/ERI or POR Reset Reset Listed under Additional Features

11.2.3 Interventions

Table 31. Arrhythmia interventions

Parameter Settings Notes

Post Mode Switch Pacing

Overdrive Period 0.5; 1; 2; 3; 5; 10; 20; 30; 60; 90;

Overdrive Rate 70; 75; 80; 90; 95; 100 … 120 ppm

Atrial Preference Pacing On; Off

Maximum Rate 80; 90; 95; 100 … 150 ppm

Interval Decrement 30; 40; 50 …100; 150 ms

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

Conducted AF Response

Maximum Rate 80; 85; 90; 95 …130 ppm

On; Off

120 min

(excluding 85 ppm for magnet operation)

On; Off Continuously On in DDIR, VDIR, or VVIR

11.3 Automatic and clinician-selectable diagnostics

Table 32.

Parameter Settings

Automatic Diagnostics

modes, or during mode switching.

Heart Rate Histogramsa (Short and Long Term, Atrial and Ventricular)

Include Refractory Senses Include; Exclude

AV Conduction Histograms (Short and Long Term)

Search AV+ Histogram

Page 31

Table 32. Automatic Diagnostics (continued)

Parameter Settings

Sensor Indicated Rate Profile

Atrial High Rate Episodes (Mode Switch On)

Collection Delay after Mode Switch 0; 1; 2 … 20; 25; 30 … 60 s

Collection Method

Frozen; Rolling

Atrial High Rate Episodes (Mode Switch Off)

Detection Rate 80; 85; 90 … 180; 200; 220; 240 … 320; 330; 350; 370; 380;

400 ppm

Detection Duration 1; 2; 3 … 20; 25; 30 … 50; 55; 60 s

Termination Beats 5; 6; 7 … 20 beats

Collection Method

Frozen; Rolling

Ventricular High Rate Episodes

Detection Rate 80; 85; 90 … 180; 200; 220; 240 … 320; 330; 350; 370; 380;

400 ppm

Detection Duration 2; 3; 4 … 198; 199; 200 beats

Termination Beats 5; 6; 7 … 20 beats

SVT Filter Off; On

Collection Method

Frozen; Rolling

Atrial Arrhythmia Trend

Atrial Arrhythmia Durations

Ventricular Rate during Atrial Arrhythmias

Rate Drop Response Episodes Based on programmed therapy

Chronic Lead Trends

Lead Monitor Counters

Sensitivity Trends Monitors chambers with Sensing Assurance

Capture Management Trend Based on use of Capture Management

Atrial Capture Management

Ventricular Capture Management

Key Parameter History

Heart Rate Histograms can be programmed to include or exclude refractory sensed events.

Collection Method applies to Atrial High Rate Episodes and Ventricular High Rate Episodes.

Table 33.

Clinician-Selectable Diagnostics

Diagnostic and parameters Parameter settings

Custom Rate Trend

Duration Beat-to-Beat; 1 Hour; 24 hours

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Table 33. Clinician-Selectable Diagnostics (continued)

Diagnostic and parameters Parameter settings

Collection Method Frozen; Rolling

Include Refractory Senses? Include; Exclude

Ventricular Capture Management Detail

EGM Collection Off; Atrial EGM; Ventricular EGM; Summed EGM

Atrial Capture Management Detail

EGM Collection Off; Atrial EGM; Ventricular EGM; Summed EGM

High Rate Detail

High Rate Type AHR and VHR; AHR; VHR

EGM Type Off; Atrial EGM; Ventricular EGM; Summed EGM

Allocation (Collection Methodb = Frozen, High Rate Type = AHR and VHR)

2 for 0/24; 2 for 24/0; 2 for 12/12; 4 for 0/12; 4 for 12/0; 4 for 6/6; 8 for 0/6; 8 for 6/0; 8 for 3/3 (number of episodes for pre-onset seconds/post onset seconds collected)

Allocation (Collection Methodb = Frozen, High Rate Type = AHR only or VHR only)

1 for 0/48; 1 for 48/0; 1 for 24/24; 2 for 0/24; 2 for 24/0; 2 for 12/12; 4 for 0/12; 4 for 12/0; 4 for 6/6; 8 for 0/6; 8 for 6/0; 8 for 3/3 (number of episodes for pre-onset seconds/post onset seconds collected)

Allocation (Collection Methodb = Rolling, High Rate Type = AHR and VHR)

2 for 16/0; 2 for 8/8; 2 for 0/24; 4 for 8/0; 4 for 4/4; 4 for 0/12; 8 for 4/0; 8 for 2/2; 8 for 0/6 (number of episodes for pre-onset seconds/post onset seconds collected)

Allocation (Collection Methodb = Rolling, High Rate Type = AHR only or VHR only)

1 for 24/0; 1 for 12/12; 1 for 0/48; 2 for 16/0; 2 for 8/8; 2 for 0/24; 4 for 8/0; 4 for 4/4; 4 for 0/12; 8 for 4/0; 8 for 2/2; 8 for 0/6 (number of episodes for pre-onset seconds/post onset seconds collected)

Pre-detection Timeout 1; 2; 3 … 12; 14; 16 … 24 weeks

Rate Drop Response Detail

Include Refractory Senses? Include; Exclude

High rate detection rate, detection duration, and termination criteria are set by parameters for the automatic diagnostic.

Collection Method is set in the High Rate automatic diagnostic.

11.4 Nonprogrammable parameters

Table 34.

Parameter Value

Magnet rate

Magnet rate 85 ppm

Magnet rate at ERI 65 ppm

Hardware parameters

Pacing rate limit (protective feature) 200 bpm

Input impedance 150 kΩ minimum

Nonprogrammable parameters

Page 33

Table 34. Nonprogrammable parameters (continued)

Parameter Value

Effective pacing capacitance 5 µF

Recommended Replacement Time (RRT) and Elective Replacement Indicator (ERI)

Battery Voltage Threshold ≤ 2.5 V, or ≤ 2.59 V and battery

impedance at ≥ 3000 Ω

Operating period between RRT and ERI 90 days

Operating period between ERI and End of Service (EOS)

EOS is set when the first pace fails to deliver at programmed pacing parameters because of depleted battery

90 days

power.

12 Device information

12.1 Physical characteristics

The following table and figure provide physical characteristics for the Attesta L DR MRI SureScan model ATDRL1 device.

Table 35. Physical characteristics: Model ATDRL1

Volume

13.1 cm

Mass 31.3 g

H x W x D

45.4 mm x 52.3 mm x 7.5 mm

Surface area 34.3 cm

Radiopaque ID

Materials in contact with human tissue

PHX

Titanium, polyurethane, silicone rubber, silicone rubber adhesive

Battery Single-cell lithium-iodine

Volume with connector holes unplugged.

Grommets may protrude slightly beyond the can surface.

The radiopaque ID 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.

The Model ATDRL1 shield graphics are shown in Figure 6.

IS-1 marking in Figure 6 refers to the International Connector Standard (see Document No. ISO 5841-3) whereby pulse generators and leads so designated are assured of meeting the electrical and mechanical parameters specified in the IS-1 International Standard.

For more information about the A-V connectors, see Figure 2.

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Figure 6. Shield graphics: Model ATDRL1

µµ

1 A = atrial

3 IS-1 marking

2 V = ventricular

12.2 Electrical specifications

12.2.1 Output waveform

The output waveform for the pacemaker is shown in Figure 7.

Figure 7. Output waveform at nominal conditions (resistive load: 500 Ω)

12.2.2 Battery information

Information about the battery used in the Attesta L DR MRI SureScan model ATDRL1 device is provided in the following table.

Note: Usable capacity is defined from the Beginning of Service (BOS) to the End of Service (EOS).

Table 36.

Battery characteristics

Manufacturer Medtronic Energy and Component Center

Model Sigma 303

Number of battery cells 1

Amplitude and pulse width measured per ISO 14708-2.

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Table 36. Battery characteristics (continued)

Type Single-cell lithium-iodine

Nominal voltage 2.8 V

Usable capacity 1.6 Ah

Residual capacity at RRT 0.16 Ah

Table 37. Current consumption for Model ATDRL1

Current consumption (at 100% pacing)

Current consumption (at 100% inhibition)

Current consumption when pacing into 500 Ω ± 1% loads at the Beginning of Service in AAIR <=>DDDR or

22.12 µA

13.87 µA

AAI<=>DDD mode at 60 bpm, 2.5 V, 0.4 ms.

Current consumption when at the Beginning of Service in AAIR <=>DDDR or AAI<=>DDD mode at 60 bpm,

2.5 V, 0.4 ms.

12.2.3 Variation with temperature

Basic rate, test pulse rate, pulse duration, and pulse amplitude remain within expected tolerances when the device temperature is between 20°C to 43°C (68°F to 109°F). Sensitivity at nominal conditions as measured at 37°C (98.6°F) can vary up to ±1% per°C, from 22°C to 45°C (72°F to 113°F).

12.3 Projected service life

12.3.1 Projected service life for Model ATDRL1

Table 38. Model ATDRL1 Projected service life from implant to RRT, in years

A Amplitude,

Pacing

V Amplitude

DDDR or DDD, 0% 1.5 V, 2.0 V

Rate,

Pulse Width

60 bpm, 0.4 ms 15.9 15.9

2.5 V, 2.5 V 14.8 14.8

3.5 V, 3.5 V 15.5 15.5

DDDR or

DDD, 50%

1.5 V, 2.0 V

2.5 V, 2.5 V 12.7 13.6

60 bpm, 0.4 ms 14.1 14.9

3.5 V, 3.5 V 11.2 12.9

AAIR<=>DDDR

or AAI<=>DDD

(MVP modes),

50% atrial,

1.5 V, 2.0 V

2.5 V, 2.5 V 13.5 14.1

3.5 V, 3.5 V 12.8 13.9

60 bpm, 0.4 ms 14.9 15.4

5% ventricular

DDDR or

DDD, 100%

1.5 V, 2.0 V

2.5 V, 2.5 V 11.1 12.6

60 bpm, 0.4 ms 12.6 14.0

3.5 V, 3.5 V 8.7 11.0

Lead impedance

500 Ω 1000 Ω

Longevity (years)

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Table 38. Model ATDRL1 Projected service life from implant to RRT, in years (continued)

Lead impedance

500 Ω 1000 Ω

Longevity (years)

Pacing

A Amplitude,

V Amplitude

Rate,

Pulse Width

DDDR or DDD, 0% 2.5 V, 2.5 V 70 bpm, 0.5 ms 14.6 —

5.0 V, 5.0 V 14.3 —

DDDR or

DDD, 100%

DDDR or

2.5 V, 2.5 V 70 bpm, 0.5 ms 9.7 —

5.0 V, 5.0 V 4.6 —

5.0 V, 5.0 V 70 bpm, 1.0 ms 2.8 —

DDD, 100%

DDDR or

5.0 V, 5.0 V 100 bpm, 1.0 ms 1.9 —

DDD, 100%

For ACM, the Minimum Adapted Amplitude is 1.5 V (nominal). For VCM, the Minimum Adapted Amplitude is

2.0 V (nominal).

12.4 Prolonged service period

At most programmed settings, approximately 95% of pacemakers have a prolonged service period of at least 90 days between RRT and ERI, and 90 days between ERI and EOS.

The prolonged service period between RRT and EOS meet the following conditions, in conformance with ISO 14708-2:

• 100% pacing in DDD mode

• 60 bpm pacing rate

• 2.5 V atrial amplitude / 0.4 ms atrial pulse width

• 2.5 V ventricular amplitude / 0.4 ms ventricular pulse width

• 600 Ω pacing load

The mean prolonged service period is 241 days.

Note: After ERI, pacing parameters including mode and rate can be reprogrammed, however this may shorten the ERI-to-EOS period.

12.4.1 Features disabled at RRT

The following features are disabled at RRT and cannot be programmed to On:

• MRI SureScan mode

• EP Studies

12.4.2 Features disabled at ERI

The following features are disabled at ERI and cannot be programmed to On:

• Single Chamber Hysteresis

• Sleep Function

• Ventricular Capture Management

• Atrial Sensing Assurance

• Ventricular Sensing Assurance

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12.5 Feature summary

This section describes the features available with the Attesta L DR MRI SureScan model ATDRL1 pacemaker.

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

Atrial Preference Pacing (APP) – The system provides an overdrive pacing technique designed to counteract potential atrial tachyarrhythmia initiating mechanisms. APP maintains a consistent activation sequence by providing continuous pacing that is closely matched to the intrinsic rate.

Automatic Polarity Configuration – This feature uses Lead Monitor to automatically configure pacing and sensing polarities for bipolar devices during Implant Detection.

Automatic PVARP – This feature protects against pacemaker-mediated tachycardia (PMT) and provides a higher 2:1 block rate, based on the mean atrial rate. Automatic PVARP enhances protection against PMT by lengthening PVARP at lower tracking rates and provides a higher 2:1 block rate by shortening PVARP and SAV (if necessary) at higher tracking rates.

Conducted AF Response – The feature regularizes the ventricular rhythm during AT/AF by modifying the pacing rate on a beat-by-beat basis to achieve pacing of just over 50% of ventricular events.

Implant Detection – Implant Detection is a 30 min period, beginning when the device is placed in the surgical pocket. During this period, the device verifies lead connection by measuring lead impedance. When the Implant Detection period is completed, various automatic features and diagnostics are activated.

Lead Monitor – This feature measures lead impedances during the life of the implanted device and controls automatic configuration of lead polarities at implant. If Lead Monitor is programmed to Adaptive, the device automatically switches bipolar pacing and sensing to unipolar pacing and sensing if the integrity of a bipolar lead is compromised.

Mode Switch – This feature switches the device from a tracking mode to a nontracking mode to prevent rapid ventricular pacing that may result from a high atrial rate, and restores the programmed pacing mode when the atrial tachyarrhythmia ends.

MRI SureScan – This feature allows patients with an implanted MRI SureScan system, including the device and leads, to have a safe MRI procedure if the requirements provided in the MRI technical manual are followed.

MVP (Managed Ventricular Pacing) – MVP promotes intrinsic conduction by reducing unnecessary right ventricular pacing. MVP operates when the programmed mode is either AAIR<=>DDDR or AAI<=>DDD.

Non-Competitive Atrial Pacing (NCAP) – This programmable feature is intended to prevent the triggering of atrial tachycardias by delaying atrial paced events scheduled to occur during the atrial relative refractory period.

Pacing mode and rate programming after ERI – The pacing mode and rate parameters can be re-programmed after the Elective Replacement Indicator (ERI) pacing mode and rate parameters have been set.

Pacemaker-Mediated Tachycardia (PMT) Intervention – This programmable feature provides automatic detection and interruption of PMTs by extending the PVARP for one interval. This ensures that the next atrial event in the PVARP will be refractory.

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

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.

Rate Adaptive AV (RAAV) – This feature varies the Paced AV (PAV) and Sensed AV (SAV) intervals as the heart rate increases or decreases during dual chamber operation to maintain 1:1 tracking and AV synchrony.

Rate Drop Response – This programmable feature provides backup pacing for patients who experience symptomatic episodes of a significant drop in heart rate. The device intervenes by elevating the pacing rate for a brief period.

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Rate Profile Optimization – The goal of Rate Profile Optimization is to ensure that the rate response remains appropriate for the full range of patient activities. 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.

Rate-responsive pacing – This feature varies the pacing rate in response to the patient’s physical motion as detected by the activity sensor of the device.

Search AV – This programmable feature searches for the patient’s intrinsic AV conduction time and adjusts the Sensed AV (SAV) and the Paced AV (PAV) intervals to promote intrinsic activation of the ventricles and to track fast atrial rates.

Sensing Assurance – This feature automatically monitors the peak amplitude of sensed signals and adjusts atrial and ventricular sensitivities within defined limits to maintain adequate sensing margins. Sensing Assurance is enabled at the completion of Implant Detection.

Sensor-varied PVARP – This programmable timing interval allows the device to automatically adjust the PVARP, based on the sensor-indicated rate. This protects against pacemaker-mediated tachycardia (PMT) and provides a higher 2:1 block rate.

Single Chamber Hysteresis – This feature enables tracking of the patient’s intrinsic rhythm below the programmed Lower Rate to prevent pacing during extended periods of inactivity, such as when a patient is sleeping.

Sinus Preference – This programmable feature is intended to improve cardiac hemodynamics by giving preference to sinus activation of the heart over sensor-driven pacing. The device searches for and then tracks an intrinsic sinus rate that is below the sensor-indicated rate in order to permit a slower intrinsic escape rate.

Sleep Function – This programmable feature suspends the programmed Lower Rate and replaces it with a Sleep Rate during a specified sleep period.

Ventricular Capture Management – This feature provides automatic monitoring of ventricular pacing thresholds. Ventricular Capture Management may be programmed to automatically adjust the ventricular Amplitude and Pulse Width settings to maintain capture.

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

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Medtronic, Inc.

*M986839A001*

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