BIOTRONIK Lumax VR ICD, Lumax DR-T ICD, Lumax VR-T ICD, Lumax DR ICD, Lumax HF-T CRT-D Technical Manual

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Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

• VR ICD

• VR-T ICD

• DR ICD

• DR-T ICD

• HF CRT-D

• HF-T CRT-D

Technical Manual

X-ray Identification

Lumax Family

Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Defibrillators Inside the housing:

X-Ray identification Year of manufacture

HR nn

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

CAUTION

Lumax Technical Manual i

Contents

1.1 System Description .......................................................1

1.2 Indications and Usage...................................................3

1.3 Contraindications...........................................................4

1.4 Warnings and Precautions ............................................4

1.4.1 Sterilization, Storage, and Handling ......................7

1.4.2 Device Implantation and Programming .................7

1.4.3 Lead Evaluation and Connection ..........................9

1.4.4 Follow-up Testing ................................................11

1.4.5 Pulse Generator Explant and Disposal ...............11

1.4.6 Hospital and Medical Hazards.............................11

1.4.7 Home and Occupational Hazards .......................13

1.4.8 Cellular Phones ...................................................13

1.4.9 Electronic Article Surveillance (EAS) ..................14

1.4.10 Home Appliances ................................................14

1.4.11 Home Monitoring .................................................15

1.5 Potential/Observed Effects of the Device on Health ...16

1.5.1 Potential Adverse Events ....................................16

1.5.2 Observed Adverse Events...................................17

1.6 Clinical Studies............................................................27

1.6.1 Kronos LV-T Study ..............................................27

1.6.2 Tupos LV/ATx Study............................................29

1.7 Patient Selection and Treatment.................................48

1.7.1 Individualization of Treatment .............................48

1.7.2 Specific Patient Populations................................49

1.8 Patient Counseling Information ...................................50

1.9 Evaluating Prospective CRT-D/ICD Patients ..............50

2.1 Cardiac Resynchronization Therapy (CRT) ................53

2.2 Sensing (Automatic Sensitivity Control) ......................56

2.2.1 Right Ventricular Sensitivity Settings...................57

2.2.2 Minimum Right Ventricular Threshold .................59

2.2.3 Atrial Sensitivity Settings .....................................59

2.2.4 Minimum Atrial Threshold....................................60

2.2.5 Left Ventricular Sensitivity Settings .....................60

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2.2.6 Minimum Left Ventricular Threshold....................61

2.2.7 Far Field Protection .............................................61

2.2.8 Additional Sensing Parameters ...........................62

2.3 Automatic Threshold Measurement (ATM) .................63

2.3.1 Functional Description.........................................63

2.4 Intra-Thoracic Impedance Measurement ....................65

2.4.1 Functional Description.........................................65

2.5 Ventricular Tachyarrhythmia Detection .......................66

2.5.1 VF Classifications ................................................67

2.5.2 VT Interval Counters............................................67

2.5.3 VT Classification..................................................67

2.5.4 SMART Detection™ ............................................68

2.5.5 Onset ...................................................................69

2.5.6 Stability ................................................................69

2.5.7 Sustained VT Timer.............................................70

2.5.8 VT Monitoring Zone .............................................70

2.5.9 Atrial Monitoring Zone .........................................71

2.6 Tachyarrhythmia Redetection......................................71

2.6.1 VT Redetection....................................................71

2.6.2 SMART Redetection............................................72

2.6.3 Forced Termination .............................................72

2.6.4 VF Redetection....................................................72

2.7 Tachyarrhythmia Termination ......................................72

2.8 Tachyarrhythmia Therapy............................................72

2.8.1 Therapy Options ..................................................73

2.8.2 Anti-Tachycardia Pacing (ATP) ...........................73

2.8.3 Shock Therapy ....................................................76

2.8.4 Progressive Course of Therapy...........................82

2.9 Bradycardia Therapy ...................................................83

2.9.1 Bradycardia Pacing Modes .................................83

2.9.2 Basic Rate ...........................................................84

2.9.3 Night Rate............................................................85

2.9.4 Rate Hysteresis ...................................................85

2.9.5 Dynamic AV Delay...............................................88

2.9.6 IOPT ....................................................................91

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2.9.7 Upper Tracking Rate ...........................................91

2.9.8 Mode Switching ...................................................93

2.9.9 PMT Management ...............................................94

2.9.10 VES Discrimination after Atrial Sensed Events ...97

2.9.11 Rate Adaptive Pacing ..........................................98

2.9.12 Pulse Amplitude...................................................99

2.9.13 Pulse Width .........................................................99

2.9.14 Post Ventricular Atrial Refractory Period...........100

2.9.15 PVARP after VES ..............................................100

2.9.16 Auto PVARP ......................................................100

2.9.17 Noise Response ................................................100

2.9.18 Post Shock Pacing ............................................101

2.10 EP Test Functions .....................................................101

2.10.1 P and R-wave Amplitude Measurements ..........101

2.10.2 Pacing Impedance Measurements....................102

2.10.3 Shock Impedance Measurements.....................103

2.10.4 Testing for Retrograde Conduction ...................103

2.10.5 Pacing Threshold...............................................104

2.10.6 Arrhythmia Induction Features ..........................104

2.10.7 Manual Shock ....................................................105

2.10.8 Test Shock.........................................................105

2.10.9 Manual ATP .......................................................106

2.10.10 Emergency Shock .............................................106

2.11 Special Features........................................................107

2.11.1 ICD Therapy Status ...........................................107

2.11.2 Home Monitoring ...............................................107

2.11.3 Real-time IEGM Transmission ..........................117

2.11.4 Capacitor Reforming .........................................118

2.11.5 Patient and Implant Data ...................................118

2.11.6 System Status ...................................................119

2.11.7 HF Monitor Statistics .........................................119

2.11.8 Holter Memory ...................................................121

2.11.9 Timing Statistics ....................................................2

2.11.10 Atrial Arrhythmias ..................................................3

2.11.11 Ventricular Arrhythmias .........................................3

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2.11.12 Sensor ...................................................................3

2.11.13 Sensing..................................................................3

2.11.14 Impedances ...........................................................4

2.11.15 Automatic Threshold..............................................4

4.1 Implant Preparation .......................................................7

4.2 Lead System Evaluation..............................................12

4.3 Opening the Sterile Container.....................................12

4.4 Pocket Preparation......................................................13

4.5 Lead to Device Connection .........................................13

4.6 Blind Plug Connection.................................................16

4.7 Program the ICD/CRT-D .............................................17

4.8 Implant the ICD/CRT-D ...............................................18

5.1 General Considerations ..............................................23

5.2 Longevity .....................................................................24

5.2.1 Lumax 300/340 Devices......................................25

5.2.2 Lumax 500/540 Devices......................................26

5.3 Explantation.................................................................29

*Lumax VR (-T) and DR (-T) ICDs do not have coronary sinus pace/sense ports ** Lumax VR (-T) ICDs do not have atrial pace/sense ports

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Lumax Specifications and Description

Battery Voltage: 3.2 Volts 300/500 models:

30 Joules programmed

Maximum Shock Energy: 340/540 models:

40 Joules programmed

Maximum Shock Energy: Defibrillation Lead Ports Two DF-1 (3.2 mm) Pacing Lead Ports Three IS-1 (3.2 mm)

(one for Lumax VR (-T) and two for

Lumax DR (-T)s) Dimensions: Volume:

See Technical Details in

Section 6

Mass: Housing Material: Titanium Header Material: Epoxy Resin Sealing Plug Material: Silicone

vi Lumax Technical Manual

Lumax Technical Manual 1

1. General

1.1 System Description

The Lumax family of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. The HF and HF-T versions of Lumax provide Cardiac Resynchronization Therapy (CRT) through biventricular pacing. Both CRT-Ds and ICDs detect and treat ventricular tachyarrhythmias and provide rate adaptive bradycardia pacing support. They are designed to collect diagnostic data to aid the physician’s assessment of a patient’s condition and the performance of the implanted device.

The Lumax family of devices provides therapy for ventricular tachyarrhythmias with a sophisticated range of programmable anti-tachycardia pacing (ATP), and/or defibrillation therapy features. The shock polarity and energy may be programmed to tailor the therapy to appropriately treat each patient's tachyarrhythmias. The ICDs/CRT-Ds provide shock therapies with programmable energies from 5 to 40 joules.

The Lumax family of ICDs/CRT-Ds includes the following members:

• Lumax HF - provides three chamber rate adaptive bradycardia pacing support including biventricular pacing via a left ventricular pacing lead. The CRT-D uses right atrial and ventricular sensing/pacing leads to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART DetectionTM algorithm.

• Lumax HF-T - In addition to the functionality found with HF model Lumax HF-T also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

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• Lumax DR - provides dual chamber rate adaptive bradycardia pacing support. The ICD uses atrial and ventricular sensing/pacing leads to provide enhanced atrial and ventricular tachyarrhythmia discrimination through BIOTRONIK’s SMART Detection

algorithm.

• Lumax DR-T - In addition to the functionality found with the DR model it also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

• Lumax VR - provides single chamber rate adaptive bradycardia pacing support as well as tachyarrhythmia detection and therapy.

• Lumax VR-T - In addition to the functionality found with standard VR model it also has the added functionality of BIOTRONIK’s Home Monitoring system. The Home Monitoring System enables automatic exchange of information about a patient’s cardiac status from the implant to the physician remotely.

The 300/500 and 340/540 designation for each of the abovedescribed models denote the maximum programmable shock energy of 30 joules and 40 joules, respectively.

The Lumax 500/540 models also feature a third programmable shock path for delivery of defibrillation/cardioversion shocks. The shock path is programmable between the different shock coils (SVC/RV) and/or the device housing. Section 2.8.3.6 provides further details on the available shock configurations.

Additionally, the Lumax 500/540 models feature Automatic Threshold Measurement (ATM) of ventricular pacing thresholds. This feature is separately programmable for the right (RV) and left (LV) ventricle. Section 2.3 provides further details.

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The Lumax HF (-T) models have three IS-1 pacing/sensing header ports and two DF-1 defibrillation/cardioversion ports. The Lumax DR (-T) models have two IS-1 pacing/sensing header ports. The Lumax VR (-T) models have one IS-1 pacing/sensing header ports. IS-1 refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992]. DF-1 refers to the international standard for defibrillation lead connectors [Reference ISO 11318:1993].

External devices that interact with and test the implantable devices are also part of the ICD/CRT-D System. These external devices include the ICS 3000 Programming and Tachyarrhythmia Monitoring System and the Implant Module System Analyzer or Pacing System Analyzer for acute lead testing. The ICS 3000 programmer is used to interrogate and program the ICD/CRT-Ds.

1.2 Indications and Usage

The Lumax CRT-Ds are indicated for use in patients with all of the following conditions:

• Indicated for ICD therapy

• Receiving optimized and stable Congestive Heart Failure

(CHF) drug therapy

• Symptomatic CHF (NYHA Class III/IV and LVEF ≤ 35%); and

• Intraventricular conduction delay (QRS duration ≥130 ms)

The Lumax Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation, for automated treatment of lifethreatening ventricular arrhythmias.

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1.3 Contraindications

The Lumax devices are contraindicated for use in patients with the following conditions:

• Patients whose ventricular tachyarrhythmias may have transient or reversible causes such as:

• Acute myocardial infarction

• Digitalis intoxication

• Drowning

• Electrocution

• Electrolyte imbalance

• Hypoxia

• Sepsis

• Patients with incessant ventricular fibrillation (VF) and

ventricular tachycardia (VT)

• Patients whose only disorder is brady arrhythmias or atrial arrhythmias

1.4 Warnings and Precautions

MRI (Magnetic Resonance Imaging) - Do not expose a patient

to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

Electrical Isolation - To prevent inadvertent arrhythmia induction, electrically isolate the patient during the implant procedure from potentially hazardous leakage currents.

Left Ventricular Lead Systems – BIOTRONIK CRT-Ds may be implanted with any legally marketed, compatible LV lead. Compatibility is defined as:

• IS-1 pacing connector

• Active or passive fixation technology

• Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1)

The following LV leads were evaluated in the OPTION CRT/ATx study with BIOTRONIK’s CRT-Ds:

• Guidant-Easytrak IS-1

• Guidant-Easytrak LV-1

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• Guidant-Easytrak 2

• Guidant-Easytrak 3

• Medtronic-Attain

• St. Jude-Aescula

• St. Jude-Quicksite

• Biomec-Myopore Epicardial

• Medtronic-Epicardial 5071

• Medtronic-CapSure EPI

• Biotronik-ELC 54-UP

The following LV leads were bench tested for compatibility with BIOTRONIK’s CRT-Ds:

• Guidant EasyTrak 4512 (unipolar)

• Guidant EasyTrak 4513 (bipolar)

• Guidant EasyTrak 3 4525 (bipolar)

• Medtronic Attain OTW 4193 (unipolar)

• Medtronic Attain OTW 4194 (bipolar)

• Medtronic Attain LV 2187 (unipolar)

• St. Jude Medical QuickSite 1056K (unipolar)

• ELA Situs OTW (unipolar)

• Biotronik Corox OTW 75-UP Steroid #346542 (unipolar)

• Biotronik Corox+ LV-H 75-BP #341885 (bipolar)

ICD Lead Systems – BIOTRONIK ICDs/CRT-Ds maybe implanted with any legally marketed, compatible ICD lead. Compatibility is defined as:

• IS-1 pacing and sensing connector(s)

• DF-1 shock coil connector(s)

• Integrated or dedicated bipolar pacing and sensing

configuration

• Active or passive fixation technology

• Single or dual defibrillation shock coil (s)

• High energy shock accommodation of at least 30 joules

• Insertion and withdrawal forces as specified by

ISO 5841-3 (IS-1) and ISO 11318:1993 (E) DF-1

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The following leads were evaluated in a retrospective study with BIOTRONIK’s ICDs/CRT-Ds:

• Medtronic Sprint 6932

• Medtronic Sprint 6943

• Medtronic Sprint Quattro 6944

• Medtronic Transvene RV 6936

• St. Jude (Ventritex) TVL- ADX 1559

• St. Jude SPL SP02

• Guidant Endotak DSP

• Guidant Endotak Endurance EZ, Endotak Reliance

• Guidant (Intermedics) 497-24.

The following leads were bench tested for compatibility with BIOTRONIK’s ICDs/CRT-Ds:

• Guidant Endotak Endurance “CPI 0125”

• Guidant Endotak Reliance 0148

• Medtronic Sprint 6932

• Medtronic Sprint 6942

• Medtronic Sprint 6943

• Medtronic Sprint 6945

• Medtronic Sprint Quattro 6944

• St. Jude Riata 1571/65

• St. Jude SPL SPO1

Resuscitation Availability - Do not perform induction testing unless an alternate source of patient defibrillation such as an external defibrillator is readily available. In order to implant the ICD/CRT-D system, it is necessary to induce and convert the patient’s ventricular tachyarrhythmias.

Unwanted Shocks – Always program ICD Therapy to OFF prior to handling the device to prevent the delivery of serious shocks to the patient or the person handling the device during the implant procedure.

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

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1.4.1 Sterilization, Storage, and Handling

Device Packaging - Do not use the device if the device’s

packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to BIOTRONIK.

Re-sterilization - Do not re-sterilize and re-implant explanted devices.

Storage (temperature) - Store the device between 5° to 45°C (41° - 113° F) because temperatures outside this range could damage the device.

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

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

Use Before Date - Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity.

1.4.2 Device Implantation and Programming

Blind Plug - A blind plug must be inserted and firmly connected

into any unused header port to prevent chronic fluid influx and possible shunting of high energy therapy.

Capacitor Reformation - Infrequent charging of the high voltage capacitors may extend the charge times of the ICD/CRT-D. The capacitors are reformed automatically at least every 85 days. For further information, please refer to Section 2.11.4, Capacitor Reforming.

Connector Compatibility – ICD/CRT-D and lead system compatibility should be confirmed prior to the implant procedure. Consult your BIOTRONIK representative regarding lead/pulse generator compatibility prior to the implantation of an ICD/CRT-D system. For further information, please refer to Appendix A.

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ERI (Elective Replacement Indicator) - Upon reaching ERI, the battery has sufficient energy remaining to continue monitoring for at least three months and to deliver a minimum of six maximum energy shocks. After this period (EOS), all tachyarrhythmia detection and therapy is disabled. Bradycardia functions are still active at programmed values until the battery voltage drops below

1.75 volts.

Magnets - Positioning of a magnet or the programming wand over the ICD/CRT-D will suspend tachycardia detection and treatment. The minimum magnet strength required to suspend tachycardia treatment is 1.8 mT. When the magnet strength decreases to less than 1 mT, the reed contact is reopened.

Programmed Parameters – Program the device parameters to appropriate values based on the patient’s specific arrhythmias and condition.

Programmers - Use only BIOTRONIK ICS 3000 programmers to communicate with the device.

Sealing System - Failure to properly insert the torque wrench into the perforation at an angle perpendicular to the connector receptacle may result in damage to the sealing system and its self-sealing properties.

Defibrillation Threshold - Be aware that the changes in the patient’s condition, drug regimen, and other factors may change the defibrillation threshold (DFT) which may result in nonconversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.

Manual Shocks – User-commanded shocks may be withheld if the ICD/CRT-D is already busy processing a manual command or the Battery Status is low.

Charge Time - When preparing a high energy shock the charge circuit stops charging the capacitors after 20 seconds, and delivers the stored energy as shock therapy. After the device reaches ERI the stored energy may be less than the maximum programmable energy for each shock.

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Shipment Mode – The shipment mode is a factory set mode that

controls the charge current of automatic capacitor reformations. This mode controls the charge current to avoid temporary low battery readings. The shipment mode is automatically deactivated as soon as electrophysiological tests (e.g., Impedance measurement) have been performed. To ensure delivery of programmed shock energy, make sure shipment mode is disabled prior to completion of implant procedure.

Shock Therapy Confirmation – Programming CONFIRMATION to OFF may increase the incidence of the ICD/CRT-D delivering inappropriate shocks.

Shock Impedance - If the shock impedance is less than twentyfive ohms, reposition the lead system to allow a greater distance between the electrodes. Never implant the device with a lead system that has measured shock impedance as less than twentyfive ohms. Damage to the device may result.

Negative AV 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.

1.4.3 Lead Evaluation and Connection

Capping Leads - If a lead is abandoned rather than removed, it

must be capped to ensure that it is not a pathway for currents to or from the heart.

Gripping Leads - Do not grip the lead with surgical instruments or use excessive force or surgical instruments to insert a stylet into a lead.

Kinking Leads - Do not kink leads. This may cause additional stress on the leads that can result in damage to the lead.

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Liquid Immersion - Do not immerse leads in mineral oil, silicone oil, or any other liquid.

Short Circuit - Ensure that none of the lead electrodes are in contact (a short circuit) during delivery of shock therapy as this may cause current to bypass the heart or cause damage to the ICD/CRT-D system.

Far-field sensing of signals from the atrium in the ventricular channel or ventricular signals in the atrial channel should be avoided by appropriate lead placement, programming of pacing/sensing parameters, and maximum sensitivity settings. If it is necessary to modify the Far Field Blanking parameter, the parameter should be lengthened only long enough to eliminate far-field sensing as evidenced on the IEGMs. Extending the parameter unnecessarily may cause under sensing of actual atrial or ventricular events.

Suturing Leads - Do not suture directly over the lead body as this may cause structural damage. Use the appropriate suture sleeve to immobilize the lead and protect it against damage from ligatures.

Tricuspid Valve Bioprosthesis - Use ventricular transvenous leads with caution in patients with a tricuspid valvular bioprosthesis.

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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1.4.4 Follow-up Testing

Defibrillation Threshold - Be aware that changes in the patient’s

condition, drug regimen, and other factors may change the defibrillation threshold (DFT), which may result in non-conversion of the arrhythmia post-operatively. Successful conversion of ventricular fibrillation or ventricular tachycardia during arrhythmia conversion testing is no assurance that conversion will occur post-operatively.

Resuscitation Availability - Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue.

Safe Program – Within the EP Test screen, pressing the “Safe Program” key on the programmer head immediately sends the safe program to the ICD/CRT-D.

1.4.5 Pulse Generator Explant and Disposal

Device Incineration – Never incinerate the ICD/CRT-D due to

the potential for explosion. The ICD/CRT-D must be explanted prior to cremation.

Explanted Devices – Return all explanted devices to BIOTRONIK.

1.4.6 Hospital and Medical Hazards

Electromagnetic interference (EMI) signals present in hospital and medical environments may affect the function of any ICD/CRT-D or pacemaker. The ICD/CRT-D is designed to selectively filter out EMI noise. However, due to the variety of EMI signals, absolute protection from EMI is not possible with this or any other ICD/CRT-D.

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The ICD/CRT-D system should have detection and therapy disabled (OFF) prior to performing any of the following medical procedures. In addition, the ICD/CRT-D should be checked after the procedures to assure proper programming:

Diathermy - Diathermy therapy is not recommended for ICD/CRT-D 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 or lead system.

Electrocautery - Electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, or may cause device malfunction or damage. If use of electrocautery is necessary, the current path and ground plate should be kept as far away from the pulse generator and leads as possible (at least 6 inches (15 cm)).

External Defibrillation - The device is protected against energy normally encountered from external defibrillation. However, any implanted device may be damaged by external defibrillation procedures. In addition, external defibrillation may also result in permanent myocardial damage at the electrode-tissue interface as well as temporary or permanent elevated pacing thresholds. When possible, observe the following precautions:

• Position the adhesive electrodes or defibrillation paddles of the external defibrillator anterior-posterior or along a line perpendicular to the axis formed by the implanted device and the heart.

• Set the energy to a level not higher than is required to achieve defibrillation.

• Place the paddles as far as possible away from the implanted device and lead system.

• After delivery of an external defibrillation shock, interrogate the ICD/CRT-D to confirm device status and proper function.

Lithotripsy - Lithotripsy may damage the ICD/CRT-D. If lithotripsy must be used, avoid focusing near the ICD/CRT-D implant site.

MRI (Magnetic Resonance Imaging) - Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient.

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Radiation - 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 and confirm its function after treatment.

Radio Frequency Ablation - Prior to performing an ablation procedure, deactivate the ICD/CRT-D during the procedure. Avoid applying ablation energy near the implanted lead system whenever possible.

1.4.7 Home and Occupational Hazards

Patients should be directed to avoid devices that generate strong electromagnetic interference (EMI) or magnetic fields. EMI could cause device malfunction or damage resulting in non-detection or delivery of unneeded therapy. Moving away from the source or turning it off will usually allow the ICD/CRT-D to return to its normal mode of operation.

The following equipment (and similar devices) may affect normal ICD/CRT-D operation: electric arc or resistance welders, electric melting furnaces, radio/television and radar transmitters, power-generating facilities, high-voltage transmission lines, and electrical ignition systems (of gasoline-powered devices) if protective hoods, shrouds, etc., are removed.

1.4.8 Cellular Phones

Testing has indicated there may be a potential interaction between cellular phones and BIOTRONIK ICD/CRT-D systems. Potential effects may be due to either the cellular phone signal or the magnet within the telephone and may include inhibition of therapy when the telephone is within 6 inches (15 centimeters) of the ICD/CRT-D, when the ICD/CRT-D is programmed to standard sensitivity.

Patients having an implanted BIOTRONIK ICD/CRT-D who operate a cellular telephone should:

• Maintain a minimum separation of 6 inches (15 centimeters) between a hand-held personal cellular telephone and the implanted device.

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• Set the telephone to the lowest available power setting, if possible.

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

Based on results to date, adverse effects resulting from interactions between cellular telephones and implanted ICDs/CRT-Ds have been transitory. The potential adverse effects could include inhibition or delivery of additional therapies. If electromagnetic interference (EMI) emitting from a telephone does adversely affect an implanted ICD/CRT-D, moving the telephone away from the immediate vicinity of the ICD/CRT-D should restore normal operation. A recommendation to address every specific interaction of EMI with implanted ICDs/CRT-Ds is not possible due to the disparate nature of EMI.

1.4.9 Electronic Article Surveillance (EAS)

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

1.4.10 Home Appliances

Home appliances normally do not affect ICD/CRT-D operation if the appliances are in proper working condition and correctly grounded and shielded. There have been reports of the interaction of electric tools or other external devices (e.g. electric drills, older models of microwave ovens, electric razors, etc.) with ICDs/CRT-Ds when they are placed in close proximity to the device.

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1.4.11 Home Monitoring

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.

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).

Event-Triggered Report – A timely receipt of the event report cannot be guaranteed. The receipt is also dependent on whether the patient was physically situated in the required coverage range of the patient device at the time the event information was sent.

Not for Diagnosis - The data transmitted by Home Monitoring are not suitable for diagnosis, because not all information available in the implant is being transmitted.

Follow-Ups - The use of Home Monitoring does not replace regular follow-up examinations. Therefore, when using Home Monitoring, the time period between follow-up visits may not be extended.

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1.5 Potential/Observed Effects of the Device on Health

1.5.1 Potential Adverse Events

The following are possible adverse events that may occur relative to the implant procedure and chronic implant of the CRT-D:

• Air embolism

• Allergic reactions to

contrast media

• Arrhythmias

• Bleeding

• Body rejection

phenomena

• Cardiac tamponade

• Chronic nerve damage

• Damage to heart valves

• Device migration

• Elevated pacing

thresholds

• Extrusion

• Fluid accumulation

• Hematoma

• Infection

• Keloid formation

• Lead dislodgment

• Lead fracture/ insulation

damage

• Lead-related thrombosis

• Local tissue reaction /

fibrotic tissue formation

• Muscle or nerve stimulation

• Myocardial damage

• Myopotential sensing

• Pacemaker mediated

tachycardia

• Pneumothorax

• Pocket erosion

• Thromboembolism

• Undersensing of intrinsic

signals

• Venous occlusion

• Venous or cardiac

perforation

Lumax Technical Manual 17

In addition, patients implanted with the ICD/CRT-D system may have the following risks. These are the same risks relate with implantation of any ICD/CRT-D system:

• Acceleration of arrhythmias (speeding up heart rhythm caused by the CRT-D)

• Dependency

• Depression

• Fear of premature

battery depletion (fear that battery will stop working before predicted time)

• Fear of shocking while awake

• Fear that shocking ability may be lost

There may be other risks associated with this device that are not currently unforeseeable.

• Anxiety about the CRT-D resulting from frequent shocks

• Imagined shock (phantom shock)

• Inappropriate detection of ventricular arrhythmias

• Inappropriate shocks

• Potential death due to

inability to defibrillate or pace

• Shunting current or insulating myocardium during defibrillation with external or internal paddles

1.5.2 Observed Adverse Events

Reported Adverse Events are classified as either observations or complications. Complications are defined as clinical events that require additional invasive intervention to resolve. Observations are defined as clinical events that do not require additional invasive intervention to resolve.

1.5.2.1 Kronos LV-T Study

NOTE:

The Kronos LV-T CRT-D is an earlier generation of BIOTRONIK devices. The Lumax CRT-Ds are based upon the Kronos LV-T and other BIOTRONIK CRT-Ds and ICDs (i.e., Tupos LV/ATx CRT-D, Lexos and Lumos families of ICDs).

18 Lumax Technical Manual

The HOME-CARE Observational study, conducted outside the US on the Kronos LV-T cardiac resynchronization defibrillator (CRT-D) in patients with congestive heart failure (CHF) involved 45 devices implanted with a cumulative implant duration of 202 months (mean implant duration of 4.5 months).

Of the 31 adverse events reported, there have been 26 observations in 23 patients and 5 complications in 3 patients with a cumulative implant duration of 202 months (16.8 patientyears). 6.7% of the enrolled patients have experienced a complication with two patients experiencing 2 separate complications. The rate of complications per patient-year was

0.30. 51% of the enrolled study patients had a reported observation with 3 patients having more than 1 observation. The rate of observations per patient-year is 1.54. Complications and observations for the patient group are summarized in Tab le 1 and

Table 2, respectively.

Table 1: Summary of Complications – Kronos LV-T

Category

Number

Patients

% of

Patient

Number

Per

patient-

year

Left Ventricular Lead Related

Dislodgement 1 2.2% 1 No Capture 1 2.2% 1

Total 2 4.4% 2

0.06

0.12

ICD Lead Related

Dislodgement 1 2.2% 1 Elevated Pacing

Threshold

12.2% 1

Total 2 4.4% 2

0.06

0.12

Unrelated to CRT-D or Leads

Hemathorax 1 2.2% 1

Total 1 2.2% 1

Overall

Complication Totals

Number of Patients = 45, Number of Patient-Years = 16.8

36.7% 5

0.06

0.30

Lumax Technical Manual 19

Table 2: Summary of Observations – Kronos LV-T

Category

Unsuccessful LV lead implant

Elevated LV pacing threshold

Phrenic nerve stimulation

Elevated DFT measurement

T-wave oversensing

Worsening CHF Elevated RV pacing

threshold Hepatitis

Arrhythmias Cardiac

Decompensation

Number

Patients

%of

Patients

Number

8 17.8% 8 0.48

5 11.1% 5 0.30

3 6.7% 3 0.18

2 4.4% 2 0.12

2 4.4% 2 0.12 2 4.4% 2 0.12

1 2.2% 1 0.06

1 2.2% 1 0.06 1 2.2% 1 0.06

1 2.2% 1 0.06

per

patient-

year

All Observations 23 51.1% 26 1.54

Number of Patients = 45, Number of Patient-Years = 16

Two patient deaths were reported during the HOME-CARE Observational Study. One death resulted from worsening heart failure and the second death resulted from cardiogenic shock due to ischemic cardiomyopathy. None of the deaths were related to the implanted CRT-D system. There were no device explants during the HOME-CARE Observational Study.

20 Lumax Technical Manual

1.5.2.2 Tupos LV/ATx Study

NOTE:

The clinical study information included in this section and in

Section 1.6.2 was performed with the Tupos LV/ATx CRT-D,

which is an earlier version of the Lumax CRT-D/ICD families. The clinical study data presented here is applicable because the Lumax family are downsized versions of the Tupos LV/ATx CRT-D and Tachos ICD families. The Lumax family is slightly different as compared to the Tupos LV/ATx (and Tachos family) in the following areas:

• Reduced size from 50/48 cc to 40/35 cc

• Addition of Home Monitoring functionality

• Addition of triggered pacing for biventricular pacing

modes

• True three chamber pacing and sensing capabilities (CRT-Ds)

The OPTION CRT/ATx study was a prospective, randomized, multi-center study to demonstrate the safety and effectiveness of the investigational Tupos LV/ATx Cardiac Resynchronization Therapy Defibrillator (CRT-D) in patients with congestive heart failure (CHF) and atrial tachyarrhythmias. All patients enrolled into the clinical study were randomly assigned to either the study group or the control group at a 2 to 1 ratio. Patients in the study group were implanted with the Tupos LV/ATx. Patients in the control group were implanted with a legally marketed ICD that provides CRT.

Of the 278 adverse events reported in the Tupos LV/ATx study group, there have been 210 observations in 104 patients and 68 complications in 50 patients with a cumulative implant duration of

1240.4 months (101.9 patient-years). 37.6% of the enrolled study patients have experienced a complication. The rate of complications per patient-year is 0.67. 78.2% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 2.06.

Lumax Technical Manual 21

Complications and observations for the Tupos LV/ATx study group are summarized in Table 3 and Ta ble

4. The total number

of patients may not equal the sum of the number of patients listed in each category, as an individual patient may have experienced more than one complication or observation.

Table 3: Summary of Complications – Tupos LV/ATx

Number

Category

Hematoma 4 3.01% 4 0.04

Pneumothorax 2 1.50% 2 0.02

Total 6 4.51% 6 0.06

Dislodgement 3 2.26% 3 0.03

Total 3 2.26% 3 0.03

High threshold/ No capture Diaphragmatic/ Intercostal stimulation (RV)

Total 3 2.26% 3 0.03

High threshold/ Intermittent biventricular capture/ No capture Unable to implant lead via coronary sinus

Dislodgement 4 3.01% 4 0.04 Diaphragmatic/

Intercostal stimulation

Total 27 20.3% 29 0.28

Patients

Procedure Related

Atrial Lead Related

2 1.50% 2 0.02

1 0.75% 1 0.01

11 8.27% 12 0.12

11 8.27% 11 0.11

1 0.75% 2 0.02

% of

Patients

ICD Lead Related

LV Lead Related

Number of

omplications

Complication

per patient-

year

22 Lumax Technical Manual

Table 3: Summary of Complications – Tupos LV/ATx

Number

Category

Infection 3 2.26% 7 0.07

Device migration 4 3.01% 4 0.04 Elective replacement

indicator reached Inductions and conversions Unable to interrogate device

Total 12 9.02% 17 0.17

Total Procedure and Device Related

Non-CHF Cardiac Symptoms Ventricular arrhythmias

Other medical 2 1.50% 2 0.02

Atrial arrhythmia 1 0.75% 1 0.01

Total 9 6.77% 10 0.10

Total – All Patients and Categories

Patients

4 3.01% 4 0.04

1 0.75% 1 0.01

43 32.33% 58 0.57

Other Medical Related

4 3.01% 4 0.04

2 1.50% 3 0.03

50 37.59% 68 0.67

% of

Patients

Device Related

Number of

omplications

Complication

per patient-

year

Number of Patients = 133, Number of Patient-Years = 101.9

* 1 Unanticipated Adverse Device Effect (UADE) occurred with a Tupos LV/ATx CRT-D during the OPTION clinical study. The device was explanted after it was unable to be interrogated with the programmer software and no pacing output was evident. The analysis showed an appropriately depleted battery and no anomalies with the IC module. The battery depletion strongly suggests that the high voltage circuit was activated over a prolonged period due to a single-bit execution path failure. The current programmer software with Automatic Battery Management (ABM) would have prevented the battery from becoming completely depleted. There were no other instances of this failure mechanism in Tupos LV/ATx devices.

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