BIOTRONIK SE and KG PRIMUS User Manual

Evia

Family of Implantable Pulse Generators

Technical Manual

Evia

Implantable Pulse Generators

Evia DR X-Ray identification

Evia DR-T X-Ray identification

Radiopaque Identification

A radiopaque identification code is visible on standard x-ray, and identifies the pulse generator:

Evia DR, DR-T, SR, and SR-T

CAUTION

Because of the numerous available 3.2-mm configurations (e.g., the IS-1 and VS-1 standards), lead/pulse generator compatibility should be confirmed with the pulse generator and/or lead manufacturer prior to the implantation of a pacing system.

IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators from different manufacturers are assured a basic fit. [Reference ISO 5841-3:1992(E)].

CAUTION

Federal (U.S.A.) law restricts this device to sale by or on the order of, a physician (or properly licensed practitioner).

Evia Technical Manual i

Contents

1. Device Description .......................................................... 1

2. Indications ........................................................................ 4

3. Contraindications ............................................................ 6

4. Warnings and Precautions ............................................. 8

4.1 Medical Therapy .......................................................... 8

4.2 Storage and Sterilization ........................................... 10

4.3 Lead Connection and Evaluation .............................. 10

4.4 Programming and Operation ..................................... 12

4.5 Home Monitoring ....................................................... 14

4.6 Electromagnetic Interference (EMI) .......................... 15

4.6.1 Home and Occupational Environments ............... 16

4.6.2 Cellular Phones .................................................... 17

4.6.3 Hospital and Medical Environments .................... 18

4.7 Pulse Generator Explant and Disposal ..................... 19

5. Adverse Events .............................................................. 21

5.1 Observed Adverse Events ........................ ................. 21

5.1.1 Dromos DR Clinical Study ................................... 21

5.1.2 PACC Clinical Study ............................................ 23

5.1.3 Inos2+ CLS Clinical Study ................................... 24

5.2 Potential Adverse Events .......................................... 26

6. Clinical Study ................................................................. 27

6.1 Dromos DR ................................. .............................. . 27

6.2 Ventricular Capture Control ....................................... 28

6.2.1 Primary Objectives ............................................... 29

6.2.2 Methods ............................................................... 29

6.2.3 Results ................................................................. 29

6.2.4 Clinical Study Conclusions .......... ......................... 34

6.3 Closed Loop Stimulation (CLS) ................................. 35

6.3.1 Protos DR/CLS Response to Mental Stress ........ 35

6.3.2 Protos DR CLS with AxVx .................................... 38

6.3.3 Inos2+ CLS ............................................................ 41

6.4 TRUST Clinical Study ................................................ 44

6.4.1 Study Overview .................................................... 44

6.4.2 Methods ............................................................... 45

6.4.3 Summary of Clinical Results ................................ 47

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6.4.4 Conclusions .......... .............................. .................. 51

7. Programmable Parameters ........................................... 53

7.1 Pacing Modes ............................................... ............. 53

7.1.1 Motion Based Rate-Adaptive Modes ................... 53

7.1.2 CLS Modes .......................................................... 53

7.1.3 Non-Rate-Adaptive Modes ................................... 54

7.1.4 Mode Switching .................................................... 55

7.1.5 Pacing Modes with Triggered Response ............. 56

7.2 Rate Related Functions ............................................. 57

7.2.1 Basic Rate ............................................................ 57

7.2.2 Rate Hysteresis .................................................... 58

7.2.3 Scan Hysteresis ................................................... 59

7.2.4 Repetitive Hysteresis ........................................... 60

7.2.5 Night Mode ........................................................... 61

7.2.6 Rate Fading . ............................... .......................... 6 2

7.3 Pulse Specific Features ............................................. 63

7.3.1 Pulse Amplitude ................................................... 63

7.3.2 Pulse Width .......................................................... 64

7.4 Automatic Sensitivity Control (ASC) ........... ............... 64

7.5 Timing Features ........................................................ 65

7.5.1 Refractory Periods ............................................... 65

7.5.2 PVARP ................................................................. 65

7.5.3 AV Delay .............................................................. 67

7.5.4 Ventricular Blanking Period .................................. 71

7.5.5 Atrial Blanking Period ........................................... 72

7.5.6 Far-Field Protection ............................................. 72

7.5.7 Safety AV Delay ................................................... 72

7.5.8 Upper Rate and UTR Response .......................... 73

7.6 Lead Polarity ............................................................. 73

7.7 Parameters for Rate-Adaptive Pacing ...................... 74

7.7.1 Sensor Gain ......................................................... 75

7.7.2 Automatic Sensor Gain ........................................ 76

7.7.3 Sensor Threshold ................................................. 77

7.7.4 Rate Increase ....................................................... 78

7.7.5 Maximum Sensor Rate ........................................ 79

7.7.6 Maximum Closed Loop Rate ................................ 79

7.7.7 Rate Decrease ..................................................... 80

7.8 Management of Specific Scenarios ........................... 81

7.8.1 2:1 Lock-In Management ..................................... 81

7.9 Atrial Upper Rate ....................................................... 82

7.10 Atrial Overdrive Pacing (Overdrive Mode) ................ 83

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7.11 Management of Specific Scenarios ........................... 84

7.11.1 PMT Management ............................................... 84

7.11.2 PMT Protection .................................................... 85

7.12 Adjustment of the PMT Protection Window .............. 86

7.13 Ventricular Capture Control (VCC) ............................ 87

7.13.1 Feature Description .................... .......................... 87

7.13.2 Ventricular Capture Control Programming........... 96

7.14 Program Consult® .................................. .................... 97

7.15 Home Monitoring (Evia DR-T) ................................. 101

7.15.1 Transmission of Information ............................... 102

7.15.2 Patient Device .................................................... 102

7.15.3 Transmitting Data ............................................... 103

7.15.4 Types of Report Transmissions ......................... 105

7.15.5 Description of Transmitted Data ........................ 106

8. St atistics ....................................................................... 109

8.1 Statistics Overview .................................................. 109

8.1.1 Timing ................................................................ 109

8.1.2 Atrial Arrhythmia ....................................... .......... 109

8.1.3 Sensor ........................... .................................... . 109

8.1.4 Sensing .............................................................. 110

8.1.5 Ventricular Arrhythmia ....................................... 110

8.1.6 Pacing ................................................................ 110

8.1.7 General Statistical Information ........................... 110

8.2 Timing Statistics ...................................................... 111

8.2.1 Event Counter .................................................... 111

8.2.2 Event Counter .................................................... 111

8.2.3 Event Episodes .................................................. 112

8.2.4 Rate Trend 24 Hours ......................................... 112

8.2.5 Rate Trend 240 Days ......................................... 112

8.2.6 Atrial and Ventricular Rate Histogram ............... 113

8.3 Arrhythmia Statistics ................................................ 113

8.3.1 Atrial Burden ...................................................... 113

8.3.2 Time of occurrence ............................................ 113

8.3.3 Mode Switching .................................................. 113

8.3.4 Ventricular Arrhythmia ....................................... 114

8.4 Sensor Statistics ...................................................... 114

8.4.1 Sensor Histogram .............................................. 114

8.4.2 Activity Report .................................................... 115

8.5 Pacing Statistics ...................................................... 115

8.5.1 Ventricular Pacing Amplitude Histogram ........... 116

8.5.2 V Pacing Threshold Trend ................................. 116

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8.5.3 Capture Control Status ...................................... 117

8.6 Sensing Statistics .................................................... 117

8.7 IEGM Snapshots ..................................................... 118

9. Other Functions/Features ........................................... 121

9.1 Safe Program Settings ............................................ 121

9.2 Magnet Effect .......................................................... 121

9.3 Temporary Programming ......................................... 122

9.4 Patient Data Memory .................... ........................... 1 23

9.5 Position Indicator .................. ........................... ........ 124

9.6 Pacing When Exposed to Interference ................... 125

10. Product Storage and Handling ................................... 126

10.1 Sterilization and Storage ......................................... 126

10.2 Opening the Sterile Container ................................. 127

10.3 Pulse Generator Orientation ................................... 128

11. Lead Connection .......................................................... 130

11. 1 Auto Initialization ..................................................... 133

12. Follow-up Procedures ................................................. 136

12.1 General Considerations .......................................... 136

12.2 Real-time IEGM Transmission ................................ 137

12.3 Threshold Test ......................................................... 137

12.4 P/R Measurement ................................................... 138

12.5 Testing for Retrograde Conduction ......................... 139

12.6 Non-Invasive Programmed Stimulation (NIPS) ....... 139

12.6.1 Description ......................................................... 139

12.6.2 Burst Stimulation ................................................ 140

12.6.3 Programmed Stimulation ................................... 140

12.6.4 Back up Pacing .................................................. 140

12.6.5 NIPS Safety Features ........................................ 141

12.7 Optimizing Rate Adaptation ..................................... 142

12.7.1 Rate/Sensor Trend ............................................. 142

12.7.2 Adjusting the Sensor Gain ................................. 143

12.7.3 Adjusting the Sensor Threshold ......................... 143

13. Elective Replacement Indication (ERI) ...................... 145

14. Explantation ................................................................. 149

14.1 Common Reasons to Explant a Pulse Generator ... 149

15. Technical Data ...................................................... ........ 153

15.1 Modes .................. ...................... .................... .......... 1 53

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15.2 Pulse- and Control Parameters ............................... 154

15.2.1 Rate Adaptation ................................................. 157

15.2.2 Ventricular Capture Control (VCC) .................... 158

15.2.3 Home Monitoring Parameters ............................ 158

15.2.4 Additional Functions ........................................... 160

15.2.5 NIPS Specifications ........................................... 161

15.3 Programmer ............................................................ 161

15.4 Materials in Contact with Human Tissue ................. 161

15.5 Electrical Data/Battery ............................................. 161

15.6 Mechanical Data .............. ................................. ....... 163

16. Order Informatio n ........................................................ 164

Appendix A ........................................................................ 166

Appendix B ........................................................................ 172

CAUTION

Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner).

vi Evia Technical Manual

Evia Technical Manual 1

1. Device Description

Evia is a multi-programmable, dual chamber pulse generator with rate-adaptive pacing. The Evia family of pulse generators is BIOTRONIK’s state of the art pacing system with two methods of rate-adaptation. Rate-adaptation is achieved through programming of either the unique principle of closed-loop stimulation (CLS) or by motion-based pacing via a capacitive accelerometer.

The basic function of CLS involves the translation of myocardial contractility into patient-specific pacing rates. Specifically, the pulse generator monitors and processes the intracardiac impedance signals associated with myocardial contraction dynamics. Changes in the waveform of this impedance signal are associated with changes in the contraction dynamics of the patient's heart due to the heart’s inotropic response to exercise and acute mental stress. By monitoring these changes, the pulse generator can provide a pacing rate that is appropriate and specific to the patient’s individual physiologic demands due to exercise and acute mental stress.

For standard motion-based rate-adaptation, the Evia is equipped with an accelerometer located within the pulse generator. This sensor produces an electric signal during physical activity of the patient. If a rate-adaptive (R) mode is programmed, then the accelerometer sensor signal controls the stimulation rate.

Evia also employs Home Monitoring™ technology, which is an automatic, wireless, remote monitoring system for management of patients with pulse generators. With Home Monitoring, physicians can review data about the patient’s cardiac status and pulse generator’s functionality between regular follow-up visits, allowing the physician to optimize the therapy process.

BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring. Refer to Section 6.4 for details regarding the study design and results. With the TRUST study, BIOTRONIK was able to show the following with regards to Home Monitoring:

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• BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation during in-office followup visits.

• A strategy of care using BIOTRONIK Home Monitoring with office visits when needed has been shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up.

• BIOTRONIK Home Monitoring-patients—who are followed remotely with office visits when needed—have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups.

• BIOTRONIK Home Monitoring provides early detection of arrhythmias.

• BIOTRONIK Home Monitoring provides early detection of silent, asymptomatic arrhythmias.

• Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK Home Monitoring allows for earlier intervention than conventional in-office follow-ups.

• BIOTRONIK Home Monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals.

Evia provides single and dual chamber pacing in a variety of rate-adaptive and non-rate adaptive pacing modes. Pacing capability is supported by a sophisticated diagnostic set.

The device is designed and recommended for use with atrial and ventricular unipolar or bipolar leads having IS-1 compatible connectors. (Note that IS-1 refers to the International Standard whereby leads and generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992]).

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Evia is designed to meet all indications for bradycardia therapy as exhibited in a wide variety of patients. The family is comprised of four pulse generators that are designed to handle a multitude of situations. The four pulse generators include:

Evia DR Evia DR-T

Evia SR Evia SR-T

Throughout this manual, specific feature and function descriptions may only be applicable to certain pulse generators of the Evia family. If specified as dual chamber configurations, the descriptions are specifically referring to Evia DR and Evia DR-T. If specified as single chamber configurations, the descriptions are specifically referring to Evia SR and Evia SR-T.

Dual chamber, rate-adaptive, unipolar/bipolar Dual chamber, rate-adaptive, unipolar/bipolar, with Home Monitoring Single chamber, rate-adaptive, unipolar/bipolar Single chamber, rate-adaptive, unipolar/bipolar, with Home Monitoring

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2. Indications

Rate-adaptive pacing with Evia pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.

Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome.

Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.

Evia Technical Manual 5

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3. Contraindications

Use of Evia pulse generators is contraindicated for the following patients:

• Unipolar pacing is contraindicated for patients with an

implanted cardioverter-defibrillator (ICD) because it may cause unwanted delivery or inhibition of ICD therapy.

• Single chamber atrial pacing is contraindicated for

patients with impaired AV nodal conduction.

• Dual chamber and single chamber atrial pacing is

contraindicated for patients with chronic refractory atrial tachyarrhythmias.

For a complete discussion of mode-specific contraindications, please refer to Appendix A

of this manual.

Evia Technical Manual 7

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4. Warnings and Precautions

Certain therapeutic and diagnostic procedures may cause undetected damage to a pulse generator, resulting in malfunction or failure at a later time. Please note the following warnings and precautions:

Magnetic Resonance Imaging (MRI) – Avoid use of magnetic resonance imaging as it has been shown to cause movement of the pulse generator within the subcutaneous pocket and may cause pain and injury to the patient and damage to the pulse generator. If the procedure must be used, constant monitoring is recommended, including monitoring the peripheral pulse.

Rate-Adaptive Pacing – Use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates.

4.1 Medical Therapy

Before applying one of the following procedures, a detailed analysis of the advantages and risks should be made. Cardiac activity during one of these procedures should be confirmed by continuous monitoring of peripheral pulse or blood pressure. Following the procedures, pulse generator function and stimulation threshold must be checked.

Therapeutic Diathermy Equipment – Use of therapeutic diathermy equipment is to be avoided for pacemaker patients due to possible heating effects of the pulse generator and at the implant site. If diathermy therapy must be used, it should not be applied in the immediate vicinity of the pulse generator/lead. The patient's peripheral pulse should be monitored continuously during the treatment.

Evia Technical Manual 9

Transcutaneous Electrical Nerve Stimulation (TENS) – Transcutaneous electrical nerve stimulation may interfere with pulse generator function. If necessary, the following measures may reduce the possibility of interference:

• Place the TENS electrodes as close to each other as possible.

• Place the TENS electrodes as far from the pulse generator/lead system as possible.

• Monitor cardiac activity during TENS use.

Defibrillation – The following precautions are recommended to minimize the inherent risk of pulse generator operation being adversely affected by defibrillation:

• The paddles should be placed anterior-posterior or along a line perpendicular to the axis formed by the pulse generator and the implanted lead.

• The energy setting should not be higher than required to achieve defibrillation.

• The distance between the paddles and the pacer/electrode(s) should not be less than 10 cm (4 inches).

Radiation – Pulse generator electronics may be damaged by exposure to radiation during radiotherapy. To minimize this risk when using such therapy, the pulse generator should be protected with local radiation shielding.

Lithotripsy – Lithotripsy treatment should be avoided for pacemaker patients since electrical and/or mechanical interference with the pulse generator is possible. If this procedure must be used, the greatest possible distance from the point of electrical and mechanical strain should be chosen in order to minimize a potential interference with the pulse generator.

Electrocautery – Electrocautery should never be performed within 15 cm (6 inches) of an implanted pulse generator or lead because of the danger of introducing fibrillatory currents into the heart and/or damaging the pulse generator. Pacing should be asynchronous and above the patient’s intrinsic rate to prevent inhibition by interference signals generated by the cautery. When possible, a bipolar electrocautery system should be used.

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For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed under the buttocks or around the thigh, but not in the thoracic area where the current pathway could pass through or near the pacing system.

4.2 Storage and Sterilization

Storage (temperature) – Recommended storage temperature

range is 5° to 55°C (41°-131°F). Exposure to temperatures outside this range may result in pulse generator malfunction (see

Section

Handling – Do not drop. If an unpackaged pulse generator is

dropped onto a hard surface, return it to BIOTRONIK (see

Section 10.1

FOR SINGLE USE ONLY - Do not resterilize the pulse

generator or accessories packaged with the pulse generator, they are intended for one-time use.

Device Packaging – Do not use the device if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK.

Storage (magnets) – Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI) to avoid damage to the device.

Temperature Stabilization – Allow the device to reach room temperature before programming or implanting the device. Temperature extremes may affect the initial device function.

Use Before Date – Do not implant the device after the USE BEFORE DATE because the device sterility and longevity may be compromised.

10.1).

4.3 Lead Connection and Evaluation

The pulse generator requires atrial and ventricular leads with IS1 compatible connectors. There are no requirements specific to the atrial lead. It is required to use a low polarization ventricular lead for activation of Ventricular Capture Control.

Evia Technical Manual 11

Ventricular Capture Control - The Ventricular Capture Control feature should be programmed OFF before lead connection. The feature is designed to measure thresholds and will automatically reprogram the ventricular pulse amplitude. In the absence of a connected lead, the feature will not be able to perform these measurements and set the output to an appropriate value.

Lead Check – The Evia pulse generators have an automatic lead check feature which may switch from bipolar to unipolar pacing and sensing without warning. This situation may be inappropriate for patients with an Implantable Cardioverter Defibrillator (ICD).

Lead/pulse Generator Compatibility – Because of the numerous available 3.2-mm configurations (e.g., the IS-1 and VS-1 standards), lead/pulse generator compatibility should be confirmed with the pulse generator and/or lead manufacturer prior to the implantation of a pacing system.

IS-1, wherever stated in this manual, refers to the international standard, whereby leads and generators from different manufacturers are assured a basic fit. [Reference ISO 58413:1992(E)].

Lead Configuration – Lead configuration determines proper programming of the pulse generator. Pacing will not occur with a unipolar lead if the lead configuration is programmed to bipolar.

Setscrew Adjustment – Back-off the setscrew(s) prior to insertion of lead connector(s) as failure to do so may result in damage to the lead(s), and/or difficulty connecting lead(s).

Cross Threading Setscrew(s) – To prevent cross threading the setscrew(s), do not back the setscrew(s) completely out of the threaded hole. Leave the torque wrench in the slot of the setscrew(s) while the lead is inserted.

Tightening Setscrew(s) – Do not overtighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque wrench into the perforation at an angle perpendicular to the

connector receptacle. Failure to do so may result in damage to the plug and its self-sealing properties.

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4.4 Programming and Operation

Negative AV Delay Hysteresis – This feature insures

ventricular pacing, a technique which has been used in patients with hypertrophic obstructive cardiomyopathy (HOCM) with normal AV conduction in order to replace intrinsic ventricular activation. No clinical study was conducted to evaluate this feature, and there is conflicting evidence regarding the potential benefit of ventricular pacing therapy for HOCM patients. In addition, there is evidence with other patient groups to suggest that inhibiting the intrinsic ventricular activation sequence by right ventricular pacing may impair hemodynamic function and/or survival.

Programming VCC – If the SA/CV sequence is not successful, program the VCC to OFF and program the pacing pulse amplitude manually.

NIPS - Life threatening ventricular arrhythmias can be induced by stimulation in the atrium. Ensure that an external cardiac defibrillator is easily accessible. Only physicians trained and experienced in tachycardia induction and reversion protocols should use non-invasive programmed stimulation (NIPS).

Unipolar/Bipolar – All Evia models can be used with either unipolar or bipolar IS-1 leads.

If the pacing or sensing function is to be programmed to bipolar, it must be verified that bipolar leads have been implanted in that chamber. If either of the leads is unipolar, unipolar sensing and pacing functions must be programmed in that chamber. Failure to program the appropriate lead configuration could result in entrance and/or exit block.

Programmers – Use only appropriate BIOTRONIK programmers equipped with appropriate software to program Evia pulse generators. Do not use programmers from other manufacturers.

Pulse Amplitude – Programming of pulse amplitudes, higher than 4.8 V, in combination with long pulse widths and/or high pacing rates can lead to premature activation of the replacement indicator.

Evia Technical Manual 13

Pacing thresholds – When decreasing programmed output (pulse amplitude and/or pulse width), the pacing threshold must first be accurately assessed to provide a 2:1 safety margin. When using the Ventricular Capture Control feature, the device will automatically set the output to the measured threshold plus the programmed Safety Margin. A new threshold search will occur at scheduled intervals or upon loss of capture.

EMI – Computerized systems are subject to EMI or “noise”. In the presence of such interference, telemetry communication may be interrupted and prevent programming.

Programming Modifications – Extreme programming changes should only be made after careful clinical assessment. Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm.

Short Pacing Intervals – Use of short pacing intervals (high pacing rates) with long atrial and/or ventricular refractory periods may result in intermittent asynchronous pacing and, therefore, may be contraindicated in some patients.

OFF Mode – Use of the OFF mode should be avoided in pacemaker dependent patients. The OFF mode can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm.

Myopotential Sensing – The filter characteristics of BIOTRONIK pulse generators have been optimized to sense electrical potentials generated by cardiac activity and to reduce the possibility of sensing skeletal myopotentials. However, the risk of pulse generator operation being affected by myopotentials cannot be eliminated, particularly in unipolar systems. Myopotentials may resemble cardiac activity, resulting in pulse generator pulse inhibition, triggering and/or emission of asynchronous pacing pulses, depending on the pacing mode and the interference pattern. Certain follow-up procedures, such as monitoring pulse generator performance while the patient is doing exercises involving the use of pectoral muscles, as well as Holter monitoring, have been recommended to check for interference caused by myopotentials. If sensing of myopotentials is encountered, corrective actions may include selection of a different pacing mode or sensitivity.

14 Evia Technical Manual

Muscle or Nerve Stimulation – Inappropriate muscle or nerve stimulation may occur with unipolar pacing when using a noncoated pulse generator.

CLS Rate-Adaptation – Under certain circumstances (e.g., EMI, lead dislodgment), the Evia device may not be able to obtain a useable impedance measurement as required for CLS rate-adaptive pacing. At this point, CLS rate-adaptation will be inactive until the situation is corrected. Rate-adaptation may be programmed to switch to motion based adaptation.

Programmed to Triggered Modes – When programmed to triggered modes, pacing rates up to the programmed upper limit may occur in the presence of either muscle or external interference.

Triggered Modes – While the triggered modes (DDT, VVT, and AAT) can be programmed permanently, the use of these modes is intended as a temporary setting in situations where maintaining the programming head in place would be impossible or impractical (i.e., during exercise testing or extended Holter monitoring) or as a short term solution to pulse generator inhibition by extracardiac interference. To avoid the potential for early battery depletion, it is important that the triggered modes are not used for long term therapy, and that the pulse generator is returned to a non-triggered permanent program.

4.5 Home Monitoring

BIOTRONIK’s Home Monitoring system is designed to notify clinicians in less than 24 hours of changes to the patient’s condition or status of the implanted device. Updated data may not be available if:

• The patient’s CardioMessenger is off or damaged and is not able to connect to the Home Monitoring system through an active telephone link.

• The CardioMessenger cannot establish a connection to the implanted device.

• The telephone and/or Internet connection do not operate properly

Evia Technical Manual 15

• The Home Monitoring Service Center is off-line (upgrades are typically completed in less than 24 hours)”

Patient’s Ability - Use of the Home Monitoring system requires the patient and/or caregiver to follow the system instructions and cooperate fully when transmitting data.

If the patient cannot understand or follow the instructions because of physical or mental challenges, another adult who can follow the instructions will be necessary for proper transmission.

Electromagnetic Interference (EMI) – Precautions for EMI interference with the Evia DR-T pulse generator are provided in

Section 4.6

electronic article surveillance systems, and others are discussed therein.

Use in Cellular Phone Restricted Areas - The mobile patient device (transmitter/receiver) should not be utilized in areas where cellular phones are restricted or prohibited (i.e., commercial aircraft).

. Sources of EMI including cellular telephones,

4.6 Electromagnetic Interference (EMI)

The operation of any implanted pulse generator may be affected by certain environmental sources generating signals that resemble cardiac activity. This may result in pulse generator pulse inhibition and/or triggering or in asynchronous pacing depending on the pacing mode and the interference pattern. In some cases (i.e., diagnostic or therapeutic medical procedures), the interference sources may couple sufficient energy into a pacing system to damage the pulse generator and/or cardiac tissue adjacent to the electrodes.

BIOTRONIK pulse generators have been designed to significantly reduce susceptibility to electromagnetic interference (EMI). However, due to the variety and complexity of sources creating interference, there is no absolute protection against EMI. Generally, it is assumed that EMI produces only minor effects, if any, in pacemaker patients. If the patient presumably will be exposed to one of the following environmental conditions, then the patient should be given the appropriate warnings.

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4.6.1 Home and Occupational Environments

The following equipment (and similar devices) may affect normal pulse generator operation: electric arc welders, electric melting furnaces, radio/television and radar transmitters, power-generating facilities, high-voltage transmission lines, electrical ignition systems (also of gasoline-powered devices) if protective hoods, shrouds, etc., are removed, electrical tools, anti-theft devices of shopping centers and electrical appliances, if not in proper condition or not correctly grounded and encased.

Patients should exercise reasonable caution in avoidance of devices which generate a strong electric or magnetic field. If EMI inhibits operation of a pulse generator or causes it to revert to asynchronous operation at the programmed pacing rate or at the magnet rate, moving away from the source or turning it off will allow the pulse generator to return to its normal mode of operation. Some potential EMI sources include:

High Voltage Power Transmission Lines – High voltage power transmission lines may generate enough EMI to interfere with pulse generator operation if approached too closely.

Home Appliances – Home appliances normally do not affect pulse generator operation if the appliances are in proper condition and correctly grounded and encased. There are reports of pulse generator disturbances caused by electrical tools and by electric razors that have touched the skin directly over the pulse generator.

Communication Equipment – Communication equipment such as microwave transmitters, linear power amplifiers, or highpower amateur transmitters may generate enough EMI to interfere with pulse generator operation if approached too closely.

Commercial Electrical Equipment – Commercial electrical equipment such as arc welders, induction furnaces, or resistance welders may generate enough EMI to interfere with pulse generator operation if approached too closely.

Evia Technical Manual 17

Electrical Appliances – Electric hand-tools and electric razors (used directly over the skin of the pulse generator) have been reported to cause pulse generator disturbances. Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with pulse generator operation.

Electronic Article Surveillance (EAS) – Equipment such as retail theft prevention systems may interact with the pulse generators. Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary.

4.6.2 Cellular Phones

Recent studies have indicated there may be a potential interaction between cellular phones and pulse generator operation. Potential effects may be due to either the radio frequency signal or the magnet within the phone and could include inhibition or asynchronous pacing when the phone is within close proximity (within 6 inches [15 centimeters]) to the pulse generator.

Based on testing to date, effects resulting from an interaction between cellular phones and the implanted pulse generators have been temporary. Simply moving the phone away from the implanted device will return it to its previous state of operation. Because of the great variety of cellular phones and the wide variance in patient physiology, an absolute recommendation to cover all patients cannot be made.

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Patients having an implanted pulse generator who operate a cellular phone should:

• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular phone and the implanted device. Portable and mobile cellular phones generally transmit at higher power levels compared to hand held models. For phones transmitting above 3 watts, maintain a minimum separation of 12 inches (30 centimeters) between the antenna and the implanted device.

• Patients should hold the phone to the ear opposite the side of the implanted device. Patients should not carry the phone in a breast pocket or on a belt over or within 6 inches (15 centimeters) of the implanted device as some phones emit signals when they are turned ON but not in use (i.e., in the listen or standby mode). Store the phone in a location opposite the side of implant.

4.6.3 Hospital and Medical Environments

Electrosurgical Caute ry – Electrosurgical cautery could induce

ventricular arrhythmias and/or fibrillation, or may cause asynchronous or inhibited pulse generator operation. If use of electrocautery is necessary, the current path (ground plate) should be kept as far away from the pulse generator and leads as possible.

Lithotripsy – Lithotripsy may damage the pulse generator. If lithotripsy must be used, do not focus the beam near the pulse generator.

External Defibrillation – External defibrillation may damage the pulse generator. Attempt to minimize current flowing through the pulse generator and lead system by following the precautions.

High Radiation Sources – High radiation sources such as cobalt 60 or gamma radiation should not be directed at the pulse generator. If a patient requires radiation therapy in the vicinity of the pulse generator, place lead shielding over the device to prevent radiation damage.

Evia Technical Manual 19

4.7 Pulse Generator Explant and

Disposal

Device Incineration - Never incinerate a pulse generator. Be

sure the pulse generator is explanted before a patient who has died is cremated (see Section 14

Explanted Devices – Return all explanted devices to BIOTRONIK.

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Evia Technical Manual 21

5. Adverse Events

NOTE:

The Evia family of pulse generators is a successor to the BIOTRONIK’s Dromos, Philos, Inos, Protos, and Cylos families of pulse generators. Therefore, data from the clinical studies of these earlier generations are used to support the safety and efficacy of the Evia family of pulse generators.

5.1 Observed Adverse Events

5.1.1 Dromos DR Clini cal Study

The Dromos DR Clinical Study involved 273 patients with cumulative implant duration of 1418 months (mean implant duration 5.2 months). Eleven patients died during the course of the trial; none of the deaths was judged to be device-related. One Dromos DR pulse generator was explanted during the trial, secondary to infection.

Table 1

per patient-month basis. The last column gives the expected time (in months) between events; i.e., the reciprocal of the AE/patient-month rate.

reports the adverse events (AE) on a per patient and a

22 Evia Technical Manual

Table 1: Adverse Events Reported in > 1 Patient

BIOTRONIK SE and KG PRIMUS User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual