BIOTRONIK SE and KG LUMAXT50 UserMan

Lumax

Family of Implantable Cardioverter

Defibrillators and Cardiac

Resynchronization Therapy

Defibrillators

 VR ICD  VR-T ICD  VR-T DX 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:

Belos Technical Manual iii

Model X-Ray Identification Year of Manufacture

Lumax 300 HR nn

Lumax 340 HR nn

Lumax 500 SH nn

Lumax 540 SH nn

Lumax 600 RH nn

Lumax 640 RH nn

Lumax 700 RH nn

Lumax 740 RH nn

CAUTION

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

Lumax Technical Manual i

Contents

1. General ..............................................................................1

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

1.2 Indications and Usage...................................................4

1.3 Contraindications...........................................................5

1.4 Warnings and Precautions ............................................5

1.4.1 Sterilization, Storage, and Handling ......................8

1.4.2 Device Implantation and Programming .................8

1.4.3 Lead Evaluation and Connection ........................10

1.4.4 Follow-up Testing ................................................12

1.4.5 Pulse Generator Explant and Disposal ...............12

1.4.6 Hospital and Medical Hazards.............................12

1.4.7 Home and Occupational Hazards .......................14

1.4.8 Cellular Phones ...................................................14

1.4.9 Electronic Article Surveillance (EAS) ..................15

1.4.10 Home Appliances ................................................15

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

1.5 Potential/Observed Effects of the Device on Health ...17

1.5.1 Potential Adverse Events ....................................17

1.5.2 Observed Adverse Events...................................18

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

1.6.1 Kronos LV-T Study ..............................................28

1.6.2 Tupos LV/ATx Study............................................30

1.6.3 Lumax HF-T V-V Clinical Study...........................48

1.6.4 TRUST Clinical Study..........................................55

1.6.5 Deikos A+ ............................................................63

1.7 Patient Selection and Treatment.................................67

1.7.1 Individualization of Treatment .............................67

1.7.2 Specific Patient Populations................................68

1.8 Patient Counseling Information ...................................68

1.9 Evaluating Prospective CRT-D/ICD Patients ..............69

2. Device Features ..............................................................70

2.1 SafeSync Telemetry ....................................................70

2.2 Cardiac Resynchronization Therapy (CRT) ................73

2.3 Sensing (Automatic Sensitivity Control) ......................76

2.3.1 Right Ventricular Sensitivity Settings...................77

2.3.2 Minimum Right Ventricular Threshold .................79

ii Lumax Technical Manual

2.3.3 Atrial Sensitivity Settings .....................................79

2.3.4 Minimum Atrial Threshold....................................80

2.3.5 Left Ventricular Sensitivity Settings .....................80

2.3.6 Minimum Left Ventricular Threshold....................81

2.3.7 Far Field Protection .............................................81

2.3.8 Additional Sensing Parameters ...........................81

2.4 Automatic Threshold Measurement (ATM) .................83

2.4.1 Signal Quality Check ...........................................84

2.4.2 Threshold Measurement .....................................84

2.4.3 Loss of Capture Detection...................................84

2.4.4 ATM in Lumax HF-T Models ...............................84

2.4.5 RV & LV Capture Control ....................................85

2.5 Ventricular Tachyarrhythmia Detection........................85

2.5.1 VF Classifications ................................................86

2.5.2 VT Interval Counters............................................86

2.5.3 VT Classification..................................................86

2.5.4 SMART Detection™ ............................................87

2.5.5 Onset ...................................................................88

2.5.6 Stability ................................................................88

2.5.7 Sustained VT Timer.............................................88

2.5.8 VT Monitoring Zone .............................................89

2.5.9 Atrial Monitoring Zone .........................................89

2.6 Tachyarrhythmia Redetection......................................90

2.6.1 VT Redetection....................................................90

2.6.2 SMART Redetection............................................90

2.6.3 Forced Termination .............................................90

2.6.4 VF Redetection....................................................91

2.7 Tachyarrhythmia Termination ......................................91

2.8 Tachyarrhythmia Therapy ............................................91

2.8.1 Therapy Options ..................................................91

2.8.2 Anti-Tachycardia Pacing (ATP) ...........................91

2.8.3 Shock Therapy ....................................................95

2.8.4 Progressive Course of Therapy.........................101

2.9 Bradycardia Therapy .................................................102

2.9.1 Bradycardia Pacing Modes ...............................102

2.9.2 Basic Rate .........................................................103

2.9.3 Night Rate..........................................................103

2.9.4 Rate Hysteresis .................................................104

2.9.5 Dynamic AV Delay.............................................107

2.9.6 IOPT ..................................................................110

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2.9.7 Upper Tracking Rate .........................................110

2.9.8 Mode Switching .................................................111

2.9.9 PMT Management .............................................113

2.9.10 VES Discrimination after Atrial Sensed Events .115

2.9.11 Rate-Adaptive Pacing........................................116

2.9.12 Pulse Amplitude.................................................118

2.9.13 Pulse Width .......................................................118

2.9.14 Post Ventricular Atrial Refractory Period...........118

2.9.15 PVARP after VES ..............................................118

2.9.16 Auto PVARP ......................................................119

2.9.17 Noise Response ................................................119

2.9.18 Post Shock Pacing ............................................119

2.10 EP Test Functions......................................................120

2.10.1 P and R-wave Amplitude Measurements ..........120

2.10.2 Pacing Impedance Measurements....................121

2.10.3 Shock Impedance Measurements.....................121

2.10.4 Testing for Retrograde Conduction ...................122

2.10.5 Pacing Threshold...............................................122

2.10.6 Arrhythmia Induction Features ..........................123

2.10.7 Manual Shock ....................................................124

2.10.8 Test Shock.........................................................124

2.10.9 Manual ATP .......................................................125

2.10.10 Emergency Shock .............................................125

2.11 Special Features........................................................125

2.11.1 ICD Therapy Status ...........................................125

2.11.2 Thoracic Impedance ..........................................126

2.11.3 Home Monitoring®.............................................126

2.11.4 Real-time IEGM Transmission ..........................138

2.11.5 Capacitor Reforming .........................................139

2.11.6 Patient and Implant Data ...................................140

2.11.7 System Status ...................................................140

2.11.8 HF Monitor Statistics .........................................141

2.11.9 Holter Memory ...................................................142

2.11.10 Timing Statistics ................................................144

2.11.11 Atrial Arrhythmias ..............................................145

2.11.12 Ventricular Arrhythmias .....................................145

2.11.13 Sensor ...............................................................146

2.11.14 Sensing..............................................................146

2.11.15 Impedances.......................................................146

2.11.16 Automatic Threshold..........................................146

2.11.17 Asynchronous Pacing Modes............................146

iv Lumax Technical Manual

2.11.18 Far-Field IEGM for Threshold Testing (Leadless

ECG)..................................................................147

2.11.19 Advanced AT/AF Diagnostics (Lumax 700/740 only)

...........................................................................147

2.11.20 Atrial NIPS (Lumax 700/740 & 600/640 only) ...148

3. Sterilization and Storage .............................................149

4. Implant Procedure ........................................................151

4.1 Implant Preparation ...................................................151

4.2 Lead System Evaluation............................................156

4.3 Opening the Sterile Container...................................156

4.4 Pocket Preparation....................................................157

4.5 Lead to Device Connection .......................................158

4.6 Blind Plug Connection...............................................161

4.7 Program the ICD/CRT-D ...........................................162

4.8 Implant the ICD/CRT-D .............................................163

5. Follow-up Procedures..................................................167

5.1 General Considerations ............................................167

5.2 Longevity ...................................................................168

5.2.1 Lumax 300/340 Devices....................................169

5.2.2 Lumax 500/540 Devices....................................171

5.2.3 Lumax 600/640 & 700/740 Devices ..................174

5.3 Explantation...............................................................176

6. Technical Specifications..............................................179

Appendix A ..........................................................................198

Appendix B – Known Anomalies.......................................200

Lumax Technical Manual v

Figure 1. Lumax 300/340 ICDs and CRT-D

VR(-T) DR(-T)/VR-T DX HF(-T)

Figure 2. Lumax 500/540, 600/640 & 700/740 ICDs and CRT-D

Table 1. Lumax Specifications

Battery Voltage 3.2 Volts Maximum Shock Energy

300/500/600/700 Models 30 Joules programmed

340/540/640/740 Models 40 Joules programmed Defibrillation Lead Ports Two DF1 (3.2 mm) Pacing Lead Ports

vi Lumax Technical Manual

VR(-T) Models One IS-1 (3.2 mm)

DR(-T)/VR-T DX Models Two IS-1 (3.2 mm)

HF(-T) Models Three IS-1 (3.2 mm) Materials

Housing Titanium

Header Epoxy Resin

Sealing Plug Silicone

Detailed technical specifications are provided in Section

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 Detection™ algorithm.

 Lumax HF-T - In addition, to the functionality found with

HF model, Lumax HF-T also has 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 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.

2 Lumax Technical Manual

 Lumax DR-T - In addition, to the functionality found with

the DR model, it also has 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 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-T DX – provides ventricular rate adaptive

bradycardia pacing support that can include atrial tracking with a single pass ICD lead and also has BIOTRONIK’s Home Monitoring system.

The 300/500/600/700 and 340/540/640/740 designation for each of the above-described models denote the maximum programmable shock energy of 30 joules and 40 joules, respectively.

The Lumax 500/540, 600/640 and 700/740 models 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. The Lumax 600/640 and 700/740 models also feature an additional left ventricular (LV) pacing polarity for HF-T devices from LV-tip to housing (unipolar).

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 2.4 provides further details.

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The Lumax 700/740 and 600/640 models feature ATM with automatic adjustment of pacing amplitudes (RV & LV Capture Control). This feature functions the same as ATM for threshold search and is also separately programmable for the right (RV) and left (LV) ventricle. In addition, it automatically adjusts the permanent pacing amplitude with a programmed safety margin. Section 2.4.5 provides a detailed description of this feature.

The Lumax 600/640 and 700/740 also provides wandless telemetry

to ease implantation and follow-up procedures. In addition, these devices include Thoracic Impedance monitoring and Atrial NIPS that can be used for an EP study to induce an arrhythmia or to burst pace a patient out of a stable tachyarrhythmia.

Lumax 700/740 and 600/640 will present with automatic Far-Field IEGM to provide a means to generate the surface ECG-like signal without the need for attaching the surface electrodes to the patients.

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 Programming and Tachyarrhythmia Monitoring System and the Implant Module System Analyzer or Pacing System Analyzer for acute lead testing. The ICS 3000 or Renamic programmer are used to interrogate and program the ICD/CRT-Ds.

The Lumax 600/640 and 700/740 models also feature SafeSync Telemetry (RF-Telemetry) via the Renamic programmer or the ICS 3000 programmer in combination with the SafeSync Module (an external communication module).

4 Lumax Technical Manual

BIOTRONIK conducted the TRUST study to evaluate the safety and effectiveness of Home Monitoring, which is available in most models of this device. Refer to Section 1.6.4 for details regarding the study design and BIOTRONIK was able to show the following with regards to Home Monitoring:

 BIOTRONIK Home Monitoring information may be used as a

replacement for device interrogation during in-office follow-up 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.

results. With the TRUST study,

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

Lumax Technical Manual 5

 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.

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)

6 Lumax Technical Manual

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

 Guidant-EASYTRAK® IS-1 Lead  Guidant-EASYTRAK LV-1 Lead  Guidant-EASYTRAK 2 Lead  Guidant-EASYTRAK 3 Lead  Medtronic-Attain® OTW Lead  St. Jude-Aescula  St. Jude-QuickSite® Lead  Biomec-Myopore

Lead

Epicardial Lead

 Medtronic-Epicardial 5071 Lead  Medtronic-CapSure® EPI Lead  BIOTRONIK-ELC 54-UP Lead

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

 Guidant EASYTRAK 4512 (unipolar) Lead  Guidant EASYTRAK 4513 (bipolar) Lead  Guidant EASYTRAK 3 4525 (bipolar) Lead  Medtronic Attain OTW 4193 (unipolar) Lead  Medtronic Attain OTW 4194 (bipolar) Lead  Medtronic Attain LV 2187 (unipolar) Lead  St. Jude Medical QuickSite 1056K (unipolar) Lead  ELA SITUS® OTW (unipolar) Lead  BIOTRONIK Corox OTW 75-UP Steroid #346542

(unipolar) Lead

 BIOTRONIK Corox+ LV-H 75-BP #341885 (bipolar) Lead

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

Lumax Technical Manual 7

 Insertion and withdrawal forces as specified by

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

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

 Medtronic Sprint  Medtronic Sprint Lead 6943  Medtronic Sprint Quattro  Medtronic Transvene  St. Jude (Ventritex) TVL

Lead 6932

RV Lead 6936

Lead 6944

- ADX Lead 1559

 St. Jude SPL® SP02 Lead  Guidant ENDOTAK® DSP Lead  Guidant ENDOTAK Endurance EZ Lead, ENDOTAK

Reliance Lead

 Guidant (Intermedics) Lead 497-24.

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

 Guidant ENDOTAK Endurance Lead “CPI 0125”  Guidant ENDOTAK Reliance Lead 0148  Medtronic Sprint Lead 6932  Medtronic Sprint Lead 6942  Medtronic Sprint Lead 6943  Medtronic Sprint Lead6945  Medtronic Sprint Quattro Lead 6944  St. Jude Riata® Lead 1571/65  St. Jude SPL SPO1 Lead.

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.

8 Lumax Technical Manual

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 90 days. For further information, please refer to Section 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

2.11.5, Capacitor

Lumax Technical Manual 9

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 or Renamic 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 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.

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.

10 Lumax Technical Manual

Programming Wand Separation Distance – The wand (with magnet) must not be placed closer than 2 cm to the device (implanted or out of the box). Programming wand (with magnet) distance closer than 2 cm may damage the device.

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 (25 Ω), 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 of less than twenty-five ohms (25 Ω). 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.

Lumax Technical Manual 11

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

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 over tighten the setscrew(s). Use only the BIOTRONIK supplied torque wrench.

Sealing System – Be sure to properly insert the torque wrench into the perforation perpendicular to the connector receptacle. Failure to do so may result in damage to the plug and its selfsealing properties.

12 Lumax Technical Manual

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.

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 procedure.

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.

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:

Lumax Technical Manual 13

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.

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.

14 Lumax Technical Manual

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.

 Set the telephone to the lowest available power setting, if

possible.

Lumax Technical Manual 15

 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

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.

implant.

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.

1.4.11 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:

16 Lumax Technical Manual

 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

 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.

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).

Lumax Technical Manual 17

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  Under sensing of intrinsic

signals

 Venous occlusion  Venous or cardiac

perforation

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In addition, patients implanted with the ICD/CRT-D system may have the following risks. These are the same risks related 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 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).

Lumax Technical Manual 19

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 Table 2

Table 3

, respectively.

and

Table 2: Summary of Complications – Kronos LV-T