Medtronic REVDD01 Implant Manual

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RELIA™ REVDD01

Dual chamber pacemaker (VDD)

Implant Manual

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

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

Capture Management, EnPulse, Intrinsic, Kappa, Medtronic, Relia, Search AV, TherapyGuide

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1 System overview 4

2 Indications 4

3 Contraindications 5

4 Warnings, precautions, and potential adverse events 5

4.1 Warnings and precautions to ensure intended device function 5

4.2 Potential adverse events 7

5 Patient selection and treatment 8

5.1 Select the pacing mode 8

5.2 Patient counseling information 9

5.3 Patient manual 9

5.4 Patient ID card 9

6 Clinical studies 9

6.1 Adverse events and clinical trial data 9

7 Implant procedure 9

7.1 Verify sufficient device longevity 10

7.2 Verify lead and connector compatibility 10

7.3 Test the lead system 11

7.4 Connect the leads to the device 11

7.5 Test the device operation 12

7.6 Position and secure the device 13

7.7 Program the device 13

7.8 Replace a device 13

8 Potential complications and emergency pacing 14

8.1 Potential complications 14

8.2 Emergency pacing 15

9 Magnet mode operation and Recommended Replacement Time (RRT/ERI)

indicators 15

9.1 Magnet mode operation 15

9.2 Recommended Replacement Time (RRT/ERI) indicators 16

10 Device parameters 16

10.1 Shipping, nominal, and electrical reset parameters 16

10.2 Programmable parameters 20

10.3 Automatic and clinician-selectable diagnostics 24

11 Device information 25

11.1 Physical characteristics 25

11.2 Electrical specifications 27

11.3 Projected service life 28

11.4 Prolonged service period 28

11.5 Feature summary 29

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1 System overview

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, contact a Medtronic representative.

This manual describes the Medtronic Relia VDD dual chamber, multiprogrammable, implantable pulse generator (IPG) bipolar/unipolar Model REVDD01. This device is also referred to as a pacemaker.

Single chamber rate response – Single chamber 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.

Additional manuals and documents with information about the device:

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 guide – 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.

2 Indications

Medtronic Relia VDD Series implantable pulse generators (IPGs) are indicated for use in patients who have experienced one or more of the following conditions:

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

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symptomatic bilateral bundle branch block

These devices are 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:

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various degrees of AV block

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

These devices are indicated for VDD pacing in patients who have adequate rates and one or both of the following conditions:

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A requirement for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome has existed or is anticipated.

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A requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal AV conduction.

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3 Contraindications

Medtronic Relia VDD Series implantable pulse generators (IPGs) are contraindicated for the following applications:

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

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Use of an implantable cardioverter defibrillator (ICD) with a unipolar-only IPG or in those cases in which unipolar leads are implanted with the IPG. Pacing in the unipolar configuration may cause the ICD to deliver inappropriate therapy or to withhold appropriate therapy.

4 Warnings, precautions, and potential adverse events

4.1 Warnings and precautions to ensure intended device function

4.1.1 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.

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 10.1, “Shipping, nominal, and electrical reset parameters”, page 16 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.

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 – 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.

Lead connection – Consider the following information when connecting the lead and the device:

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Cap abandoned leads to avoid transmitting electrical signals.

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Plug any unused lead ports to protect the device.

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

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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.

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.

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-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.

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.

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 with bipolar models. Electrical leakage may cause a loss of output.

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.

4.1.2 Device system warnings and precautions for pacemaker-dependent patients

Asynchronous pacing mode – The VOO asynchronous pacing mode disables sensing. It is not appropriate to

permanently program this pacing mode for pacemaker-dependent patients.

Diagnostic modes – Do not program diagnostic modes (ODO, OVO, and OAO) for pacemaker-dependent patients. 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.

4.1.3 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.

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4.1.4 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.

Temperature limits – Store and transport the package between –18°C and +55°C (0°F and 131°F). Electrical 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 device 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.

4.1.5 Explant and disposal

Consider the following information related to device explant and disposal:

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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.

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

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

4.2 Potential adverse events

Potential adverse events associated with the use of a device system (defined as the device and leads) include, but are not limited to, the following:

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Air embolism

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Allergic reaction

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Bleeding

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Body rejection phenomena including local tissue rejection

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Cardiac dissection

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Cardiac perforation

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Cardiac tamponade

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Chronic nerve damage

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Death

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Embolism

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Endocarditis

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Erosion of the device and lead through the skin

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Excessive fibrosis

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Extrusion

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Fibrillation or other arrhythmias

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Fluid accumulation

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Formation of cysts

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Heart block

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Heart wall rupture

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Hematoma/seroma

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Inappropriate acceleration of arrhythmias

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Infection

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Keloid formation

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Lead abrasion and discontinuity

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Lead migration/dislodgment

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Muscle and nerve stimulation

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Myocardial damage

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Myocardial irritability

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Myopotential sensing

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Pericardial effusion

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Pericardial rub

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Pneumothorax

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Threshold elevation

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Thromboemboli

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Thrombosis

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Transvenous lead-related thrombosis

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Valve damage (particularly in fragile hearts)

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Venous occlusion

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Venous perforation

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Vein wall rupture

5 Patient selection and treatment

5.1 Select the pacing mode

TherapyGuide offers a simple clinically-focused method for a clinician to obtain suggested parameter values. At implant or an early follow-up appointment, the clinician enters information about the patient’s clinical conditions. Based on those inputs the programmer suggests parameter settings. The suggestions are based on clinical studies, literature, current practice, and the consensus of physicians.

TherapyGuide suggests a programmable mode based on clinical conditions such as the condition of the sinus node and the quality of AV conduction.

TherapyGuide offers a Rationale screen that shows the basis for each setting of pacing modes and of other parameters. To access the screen, perform the following steps:

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1. Interrogate the pacemaker following implant.

2. Select the Params icon. On the Therapy Parameters screen, select the [TherapyGuide] button to open the TherapyGuide window.

3. Select the [Rationale…] button to open the Rationale window.

4. Select [Close] twice to return to the Therapy Parameters screen.

Note: Refer to the Pacemaker Programming Guide for instructions on programming parameters using TherapyGuide.

5.2 Patient counseling information

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

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

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Review instructions to the patient concerning physical activity.

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

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

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

5.3 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.

5.4 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.

6 Clinical studies

6.1 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:

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.

7 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.

The implant procedure includes the following steps:

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Verify sufficient device longevity.

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Verify lead and connector compatibility.

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Test the lead system.

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Connect the leads to the device.

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Test the device operation.

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Position and secure the device.

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Program the device.

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Replace a device.

7.1 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.

7.2 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, result in electrical current leakage, or result in an intermittent electrical connection.

Select a compatible lead. Refer to the following table.

Table 1. Lead and connector compatibility

Connector Polarity Compatibility

Ventricular Bipolar/Unipolar Compatible with the IS-1 standard for unipolar and

bipolar pacing and sensing

Atrial Bipolar Compatible with the mechanical requirements of the

IS-1 standard, but is only designed for sensing

IS-1 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.

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7.2.1 Connector dimensions

Ø 1.93 mm (2x)

Ø 3.5 mm (2x)

17.5 mm (2x)

23.7 mm (2x)

The following figure shows the connector dimensions for the Relia REVDD01 device.

Figure 1. REVDD01 IS-1 connector dimensions

7.3 Test the lead system

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

7.4 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.

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Figure 3. Wrench in the grommet

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 The lead pin is 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.

7.5 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:

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

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

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

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

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7.6 Position and secure the device

Warning: Electrosurgical cautery may induce ventricular arrhythmias or may cause device malfunction or

damage. If electrosurgical cautery cannot be avoided, observe the following precautions to minimize complications:

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Keep temporary pacing and defibrillation equipment available.

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Use a bipolar electrocautery system if possible.

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Use short, intermittent, and irregular bursts at the lowest appropriate energy levels.

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Avoid direct contact with the device or leads. If unipolar cautery is used, position the ground plate so the current pathway does not pass through or near the device and lead. The current pathway should be a minimum of 15 cm (6 in) away from the device and lead.

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Program the device to an asynchronous pacing mode for pacemaker-dependent patients.

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.

Figure 5. Location of suture hole

1 Suture hole

5. Suture the pocket incision closed.

7.7 Program the device

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.

7.8 Replace a device

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

pacemaker-dependent patients are without pacing support.

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See Section 7.6, “Position and secure the device”, page 13 for additional warnings.

If you are replacing a previously implanted device, perform the following steps:

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 7.3, “Test the lead system”, page 11). 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 7.4, “Connect the leads to the device”, page 11). Note: Lead adaptors may be needed to connect the leads to the replacement device (see Section 7.2, “Verify lead and connector compatibility”, page 10). Contact a Medtronic representative for questions about compatible lead adaptors.

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.

8 Potential complications and emergency pacing

8.1 Potential complications

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

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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.

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

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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, RRT/ERI, and erratic pacing.

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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.

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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.

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Electromagnetic interference (EMI) from electrocautery and defibrillation may cause pacing output inhibition, temporary pause in pacing, permanent loss of pacing output, reversion to asynchronous mode, pacing synchronized to the EMI source, set the RRT/ERI, and a partial or full electrical reset condition.

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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.

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

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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.

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8.2 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

9 Magnet mode operation and Recommended Replacement Time (RRT/ERI) indicators

9.1 Magnet mode operation

Magnet operation may be initiated by performing one of the following actions:

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Placing a transtelephonic magnet over the IPG

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Performing a magnet test from the programmer

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.

The following responses occur automatically during magnet mode operation:

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The device performs a Threshold Margin Test (TMT) to allow a check for loss of capture. A TMT is performed at 100 ppm with the amplitude reduced by 20% on the third pulse. Warning: Loss of capture during a TMT at a 20% reduction in amplitude indicates an inadequate safety margin. As soon as possible, perform a pacing threshold test and reprogram outputs to establish a 2:1 stimulation safety margin. Note: When Transtelephonic Monitor is set to On, TMT is delayed for 5 s to enhance communication with transtelephonic equipment.

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The magnet rate for normal operation switches to a rate of 85 ppm and the appropriate asynchronous mode, see the following table for mode information.

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The magnet rate becomes 65 ppm when the Recommended Replacement Time (RRT/ERI) is set or when an electrical reset has occurred.

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Programmed mode Magnet mode

VDD VOO

Single chamber VOO

9.2 Recommended Replacement Time (RRT/ERI) indicators

The Recommended Replacement Time (RRT/ERI) warns when the device battery is nearing depletion. When the battery voltage has dropped below a defined limit, the device sets the RRT/ERI status and reverts to VVI operation at a rate of 65 ppm. At most programmed settings, the majority of devices will function for a minimum of 3 months after RRT/ERI.

The device’s Recommended Replacement Time (RRT/ERI) indicators are listed in the following table.

Table 3. Recommended Replacement Time (RRT/ERI) indicator status

Operation Indicator

Nonmagnet mode VVI mode at 65 ppm

Magnet mode VOO mode at 65 ppm

Telemetry Replacement message on the programmer

Battery/Lead information Replacement message and displayed battery voltage

on programmer

10 Device parameters

10.1 Shipping, nominal, and electrical reset parameters

Notes:

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“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.

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

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After certain serious device errors, the pacemaker will recover as a model RES01. If this occurs, contact a Medtronic representative.

Table 4. Mode and rates

Partial electri-

Parameter Shipping Medtronic nominal

cal reset

Mode and rates

Mode VDD VDD Unchanged VVI

Mode Switch Off Off Unchanged Off

Detect Rate 175 bpm 175 bpm 175 bpm 175 bpm

Detect Duration No Delay No Delay No Delay No Delay

Blanked Flutter

On On Unchanged On

Lower Rate 50 ppm 50 ppm Unchanged 65 ppm

Full electrical reset

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Table 4. Mode and rates (continued)

Parameter Shipping Medtronic nominal

Partial electrical reset

Full electrical reset

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

Medtronic nominal

Partial electrical reset

Full electrical reset

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

Table 6. Atrial Lead

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

Sensitivity 0.25 mV 0.25 mV Unchanged 0.25 mV

Sensing Polarity Bipolar Bipolar Unchanged Bipolar

Table 7. Ventricular Lead

Parameter Shipping

Amplitude

3.5 V (Adaptive) 3.5 V (Adap-

Medtronic nominal

Partial electrical reset Full electrical reset

Unchanged 5.0 V

tiveb)

Pulse Width 0.4 ms (Adaptive) 0.4 ms

Unchanged 0.4 ms

(Adaptiveb)

Sensitivity 2.8 mV 2.8 mV Unchanged 2.8 mV

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

Page 18

Table 7. Ventricular Lead (continued)

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

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 models revert to Implant Detection during which polarity is automatically configured.

Table 8. Ventricular Capture Management

Parameter Shipping

Medtronic nominal

Partial electrical reset Full electrical reset

Ventricular Capture

Adaptive Adaptive Unchanged Off

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

V. Sensing during

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 9. Intrinsic Activation and AV Intervals

Medtronic

Parameter Shipping

nominal

Sensed AV (SAV) 120 ms 120 ms

Partial electrical reset

120 ms

Full electrical reset

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

Search AV+ On On Unchanged Off

Max Increase to AV 170 ms 170 ms Unchanged 110 ms

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.

Page 19

Table 10. 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

Ventricular Refractory

230 ms 230 ms 230 ms 230 ms

Period

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

Table 11. 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 22:00 22:00 22:00 22:00

Wake Time 08:00 08:00 08:00 08:00

Single Chamber Hyste-

Off Unchanged Unchanged Off

resis

PMT Intervention Off Off Unchanged Off

PVC Response On On Unchanged On

Implant Detection On/Restart Unchanged Unchanged On/Restart

Table 12. Interventions

Parameter Shipping

Conducted AF Response

Off Off Unchanged Off

Medtronic nominal

Partial electrical reset Full electrical reset

Maximum Rate 110 bpm 110 bpm 110 bpm 110 bpm

This feature was named Ventricular Response Pacing in EnPulse.

Table 13. 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

Page 20

10.2 Programmable parameters

Caution: Do not program device parameters before implant. Do not program Rate Response until after Implant

Detection is complete.

Note: In the event of a component failure, the runaway rate limit is held to 200 ppm, and is not an adjustable parameter. Rate limit is automatically overridden in temporary single chamber modes for high-rate pacing.

Table 14. Mode and rates

Parameter Settings Notes

Mode VDD; VVIR; VVI; VVT; VOOR; VOO; VDI;

VDIR; ODO; OVO; OAO

Mode Switch On; Off

Detect Rate 120; 125; 130 … 200 bpm

Detect Duration No Delay; 10; 20 … 60 s

Blanked Flutter Search On; Off

Lower Rate

Upper Tracking Rate 80; 90; 95 … 180 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.

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

Table 15. 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

Page 21

Table 16. Atrial Lead

Parameter Settings Notes

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 Polarity Bipolar Non-programmable.

Warning: Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity from its nominal setting to a more sensitive setting.

Table 17. 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)

Sensitivity

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

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

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

11.2 mV

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 Off; Configure; Monitor Only; Adap-

tive

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.

Warning: Carefully evaluate the possibility of increased susceptibility to EMI and oversensing before changing the sensitivity from its nominal setting to a more sensitive setting.

Table 18. Ventricular Capture Management

Parameter Settings Notes

Ventricular Capture

Off; Monitor Only; Adaptive

Management

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

Page 22

Table 18. Ventricular Capture Management (continued)

Parameter Settings Notes

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 00:00; 01:00 … 23:00 Applies only for Day(s) at … parameter.

Acute Phase Days Remaining

V. Sensing during

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

Unipolar; Bipolar; Adaptive

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

Table 19. Intrinsic Activation and AV Intervals

Parameter Settings Notes

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

Table 20. 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

Table 21. Additional Features

Parameter Settings Notes

Sleep Function On; Off

Sleep Rate 30; 35; 40 … 90 ppm

(except 65 and 85 ppm)

Bed Time 00:00; 00:15; 00:30 … 23:45

Wake Time 00:00; 00:15; 00:30 … 23:45

Page 23

Table 21. Additional Features (continued)

Parameter Settings Notes

Single Chamber Hyste-

Off; 40; 50; 60 ppm

resis

PMT Intervention On; Off

PVC Response On; Off

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 22. 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

Table 23. Status (reset) parameters

Parameter Settings Notes

Ventricular Lead Status Reset Indicator

RRT/ERI or POR Reset Reset Listed under Additional Features

Table 24. Temporary parameters

Parameter Settings Notes

Chamber Atrium; Ventricle Setting determines available modes.

Mode VDD; VDI; VVI; VVT; VOO; ODO;

OVO; OAO

Lower Rate 30; 35; 40 … 180 ppm (except 65 and

85 ppm)

Availability of modes is dependent on programmed mode.

Rates above 180 ppm are available by

selecting the enable button. 190; 200; 210 … 250 ppm 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; 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

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

Page 24

10.3 Automatic and clinician-selectable diagnostics

Table 25. Automatic diagnostics

Parameter Settings

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

Atrial High Rate Episodes (Mode Switch On)

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

Collection Method

Atrial High Rate Episodes (Mode Switch Off)

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

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;

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

Termination Beats 5; 6; 7 … 20 beats

SVT Filter Off; On

Collection Method

Chronic Lead Trends

Lead Monitor Counters

Ventricular Capture Management Trend

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.

Frozen; Rolling

400 ppm

Frozen; Rolling

Table 26. Clinician Selected diagnostics

Diagnostic and parameters Parameter settings

Custom Rate Trend

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

Collection Method Frozen; Rolling

Include Refractory Senses? Include; Exclude

Page 25

Table 26. Clinician Selected diagnostics (continued)

Diagnostic and parameters Parameter settings

Ventricular Capture Management Detail

EGM Collection Off; AEGM; VEGM; Summed

High Rate Detail

High Rate Type AHR; VHR

EGM Type Off; AEGM; VEGM; Summed

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

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

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

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

Collection Method is set in the High Rate automatic diagnostic.

11 Device information

11.1 Physical characteristics

The following table and figure provide physical characteristics for the Relia Model REVDD01 device.

Table 27. Physical characteristics

Volume

11.1 cm

Mass 23.6 g

H x W x D

44.7 mm x 42.9 mm x 7.5 mm

Surface area 26.9 cm

Radiopaque ID

Materials in contact with human tissue

PWB

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.

Page 26

Figure 6. Radiopaque ID

The Model REVDD01 shield graphics are shown in Figure 7.

IS-1 marking in Figure 7 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.

Figure 7. Shield graphics: Model REVDD01

1 Device serial number 2 Code for country of manufacture

Page 27

11.2 Electrical specifications

µµ

11.2.1 Output waveform

The output waveform for the pacemakers is provided in Figure 8.

Figure 8. Output waveform at nominal conditions (resistive load: 500 Ω)

11.2.2 Battery information

Information about the battery used in the pacemaker models is provided in the following table.

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

Table 28. Battery and power consumption for Model REVDD01

Parameter Capability Notes

Model Sigma 213

Type Single-cell lithium-iodine

Manufacturer Medtronic Energy and

Component Center

Voltage 2.8 V

Usable capacity 0.93 Ah Capacity available from BOS to EOS

Minimum capacity at RRT/ERI 0.07 Ah Minimum capacity is measured at nomi-

nal settings, 500 Ω load in unipolar or bipolar polarity, 100% pacing

Device input impedance > 150 kΩ Device input impedance is measured to

CENELEC standard (EN 45502-2-1)

Table 29. Current consumption

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 VDD mode at 60 bpm,

2.5 V, 0.4 ms.

Current consumption when at the Beginning of Service in VDD mode at 60 bpm, 2.5 V, 0.4 ms.

17.31 µA

12.93 µA

Amplitude and pulse width measured per ISO 14708-2.

Page 28

11.2.3 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).

11.3 Projected service life

11.3.1 Projected service life: Model REVDD01 with serial number prefix NWX

Table 30. REVDD01 Projected service life from implant to RRT/ERI in years (serial number prefix NWX)

Lead impedance

A Amplitude,

Pacing

VDD, 0% 2.0 V 60 bpm, 0.4 ms 9.8 9.8

VDD, 50% 2.0 V 60 bpm, 0.4 ms 9.1 9.4

VDD, 100% 2.0 V 60 bpm, 0.4 ms 8.5 9.0

VDD, 0% 2.5 V 70 bpm, 0.5 ms 9.0 —

VDD, 100% 2.5 V 70 bpm, 0.5 ms 7.1 —

VDD, 100% 5.0 V 70 bpm, 1.0 ms 3.0 —

VDD, 100% 5.0 V 100 bpm, 1.0 ms 2.2 —

V Amplitude

2.5 V 9.1 9.1

3.5 V 9.5 9.5

2.5 V 8.4 8.7

3.5 V 7.9 8.6

2.5 V 7.7 8.3

3.5 V 6.8 7.9

5.0 V 8.8 —

5.0 V 4.3 —

Rate,

Pulse Width

500 Ω 1000 Ω

Longevity (years)

Note: VDD longevity is calculated with the following conditions: Dual chamber device, DDD mode, 0.0 V amplitude

in the atrium (atrial pacing disabled).

11.4 Prolonged service period

At most programmed settings, approximately 95% of the pacemakers will achieve a prolonged service period of at least 3 months after RRT/ERI is set.

The 3-month prolonged service period between RRT/ERI and EOS assumes 100% VVI pacing at a programmed rate of 65 bpm, RV amplitude of 3.5 V, RV pulse width of 0.4 ms, and pacing load of 500 Ω. Reprogramming the parameters may reduce the duration of the prolonged service period.

Page 29

11.5 Feature summary

This section describes the features available with the Relia REVDD01 pacemaker.

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.

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.

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 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.

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.

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.

Page 30

Page 31

Page 32

Medtronic, Inc.

*M960739A001*

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

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Technical manuals

www.medtronic.com/manuals