BIOTRONIK SE and KG LUMAXT UserMan
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
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X-ray Identification
Lumax Family
Implantable Cardioverter Defibrillator and
Cardiac Resynchronization Therapy Defibrillators
Inside the housing:
X-Ray identification Year of manufacture
HR nn
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
©2006 BIOTRONIK, Inc., all rights reserved.
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Lumax Technical Manual i
Contents
1. General .................................................................................6
1.1 System Description ..........................................................6
1.2 Indications and Usage......................................................8
1.3 Contraindications.............................................................. 9
1.4 Warnings and Precautions ...............................................9
1.4.1 Sterilization, Storage, and Handling ....................... 12
1.4.2 Device Implantation and Programming ..................12
1.4.3 Lead Evaluation and Connection ...........................14
1.4.4 Follow-up Testing ................................................... 16
1.4.5 Pulse Generator Explant and Disposal ..................16
1.4.6 Hospital and Medical Hazards................................ 16
1.4.7 Home and Occupational Hazards ..........................18
1.4.8 Cellular Phones ...................................................... 18
1.4.9 Electronic Article Surveillance (EAS) .....................19
1.4.10 Home Appliances ................................................... 20
1.4.11 Home Monitoring ....................................................20
1.5 Potential and Observed Effects of the Device on Health21
1.5.1 Potential Adverse Events .......................................21
1.5.2 Observed Adverse Events...................................... 22
1.6 Clinical Studies...............................................................32
1.6.1 Kronos LV-T Study ................................................. 32
1.6.2 Tupos LV/ATx Study............................................... 34
1.7 Patient Selection and Treatment....................................54
1.7.1 Individualization of Treatment ................................54
1.7.2 Specific Patient Populations...................................56
1.8 Patient Counseling Information ...................................... 56
1.9 Evaluating Prospective CRT-D/ICD Patients .................57
2. Device Features ................................................................. 58
2.1 Cardiac Resynchronization Therapy (CRT) ................... 58
2.2 Sensing (Automatic Sensitivity Control) ......................... 61
2.2.1 Right Ventricular Sensitivity Settings...................... 61
2.2.2 Minimum Right Ventricular Threshold ....................64
2.2.3 Atrial Sensitivity Settings ........................................ 64
2.2.4 Minimum Atrial Threshold.......................................65
2.2.5 Left Ventricular Sensitivity Settings ........................ 65
2.2.6 Minimum Left Ventricular Threshold....................... 65
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ii Lumax Technical Manual
2.2.7 Far Field Protection ................................................ 65
2.2.8 Additional Sensing Parameters .............................. 66
2.3 Ventricular Tachyarrhythmia Detection........................... 67
2.3.1 VF Classifications ................................................... 68
2.3.2 VT Interval Counters............................................... 69
2.3.3 VT Classification.....................................................69
2.3.4 SMART Detection™ ............................................... 69
2.3.5 Onset ...................................................................... 70
2.3.6 Stability ................................................................... 71
2.3.7 Sustained VT Timer................................................71
2.4 Tachyarrhythmia Redetection.........................................72
2.4.1 VT Redetection.......................................................72
2.4.2 SMART Redetection...............................................72
2.4.3 Forced Termination ................................................73
2.4.4 VF Redetection.......................................................73
2.5 Tachyarrhythmia Termination .........................................73
2.6 Tachyarrhythmia Therapy ............................................... 73
2.6.1 Therapy Options ..................................................... 73
2.6.2 Anti-Tachycardia Pacing (ATP) .............................. 74
2.6.3 Shock Therapy .......................................................76
2.6.4 Progressive Course of Therapy.............................. 81
2.7 Bradycardia Therapy ...................................................... 82
2.7.1 Bradycardia Pacing Modes ....................................82
2.7.2 Basic Rate ..............................................................83
2.7.3 Night Rate............................................................... 83
2.7.4 Rate Hysteresis ...................................................... 84
2.7.5 Dynamic AV Delay.................................................. 87
2.7.6 IOPT Plus ...............................................................90
2.7.7 Upper Tracking Rate ..............................................90
2.7.8 Mode Switching ...................................................... 91
2.7.9 PMT Protection.......................................................93
2.7.10 VES Discrimination after Atrial Sensed Events ...... 93
2.7.11 Rate Adaptive Pacing .............................................94
2.7.12 Pulse Amplitude......................................................95
2.7.13 Pulse Width............................................................. 95
2.7.14 Post Ventricular Atrial Refractory Period................96
2.7.15 PVARP after VES ...................................................96
2.7.16 Auto PVARP ...........................................................96
2.7.17 Noise Response .....................................................96
2.7.18 Post Shock Pacing .................................................96
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2.8 EP Test Functions...........................................................97
2.8.1 P and R-wave Amplitude Measurements...............97
2.8.2 Pacing Impedance Measurements.........................98
2.8.3 Shock Impedance Measurements..........................98
2.8.4 Testing for Retrograde Conduction ........................98
2.8.5 Pacing Threshold.................................................... 99
2.8.6 Arrhythmia Induction Features .............................100
2.8.7 Manual Shock.......................................................101
2.8.8 Test Shock............................................................101
2.8.9 Manual ATP ..........................................................102
2.8.10 Emergency Shock ................................................ 102
2.9 Special Features...........................................................102
2.9.1 ICD Therapy Status .............................................. 102
2.9.2 Home Monitoring .................................................. 103
2.9.3 Real-time IEGM Transmission .............................110
2.9.4 Capacitor Reforming.............................................110
2.9.5 Patient and Implant Data ...................................... 111
2.9.6 System Status.......................................................111
2.9.7 HF Monitor Statistics ............................................112
2.9.8 Holter Memory ...................................................... 113
2.9.9 Real-time IEGM .................................................... 116
2.9.10 Timing Statistics ................................................... 116
2.9.11 Atrial Arrhythmias .................................................117
2.9.12 Ventricular Arrhythmias ........................................117
2.9.13 Sensor ..................................................................117
2.9.14 Sensing .................................................................117
2.9.15 Impedances .......................................................... 117
3. Sterilization and Storage................................................. 118
4. Implant Procedure ........................................................... 120
4.1 Implant Preparation ...................................................... 120
4.2 Lead System Evaluation............................................... 124
4.3 Opening the Sterile Container......................................124
4.4 Pocket Preparation.......................................................125
4.5 Lead to Device Connection ..........................................126
4.6 Blind Plug Connection .................................................. 128
4.7 Program the ICD/CRT-D ..............................................129
4.8 Implant the ICD/CRT-D ................................................130
5. Follow-up Procedures.....................................................133
5.1 General Considerations................................................133
5.2 Longevity ......................................................................134
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5.3 Explantation.................................................................. 136
6. Technical Specifications.................................................139
Appendix A .............................................................................149
*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 Technical Manual v
Lumax Specifications and Description
Battery Voltage: 3.2 Volts
300 models:
Maximum Shock Energy:
340 models:
Maximum Shock Energy:
Defibrillation Lead Ports Two DF-1 (3.2 mm)
Pacing Lead Ports Three IS-1 (3.2 mm)
Dimensions:
Volume:
Mass:
Housing Material: Titanium
Header Material: Epoxy Resin
Sealing Plug Material: Silicone
30 joules programmed
26.6 joules delivered
40 joules programmed
35.7 joules Delivered
(one for Lumax VR (-T)
and two for
Lumax DR (-T)s)
See Technical Details in
Section 6
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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 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 include 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
• 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.
TM
algorithm.
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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
TM
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 and 340 reference for each of the above-described
models denote the maximum programmable shock energy of 30
joules and 40 joules, respectively.
All members of the Lumax device family have two DF-1
defibrillation/ cardioversion ports. In addition, the Lumax HF (-T)
models have three IS-1 pacing/sensing header 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].
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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 for
acute lead testing. This programmer is used to interrogate and
program the ICD/CRT-D.
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 bradyarrhythmias 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 maybe
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:
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• Guidant-Easytrak IS-1
• Guidant-Easytrak LV-1
• 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
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• 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
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.
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Unwanted Shocks – Always program Therapy status 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.
High Output Settings – High ventricular or biventricular pacing
voltage settings may significantly reduce the life expectancy of
the CRT-Ds. Programming of pulse amplitudes, higher than 4.8V,
in combination with long pulse widths and/or high pacing rates
may lead to early activation of replacement indicators.
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 55°C
(41° - 131° 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.
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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 and
may be reformed manually. For further information, please refer
to Section 2.9.4
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
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 30 joule
shocks. After this period, all tachyarrhythmia detection and
therapy is disabled. Bradycardia functions are still active at
programmed values until the battery voltage drops below
3.0 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.
, Capacitor Reforming.
.
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.
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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.
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 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.
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.
Liquid Immersion - Do not immerse leads in mineral oil, silicone
oil, or any other liquid.
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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 does not immediately
send the safe program to the ICD/CRT-D. Pressing the “Safe
Program” key activates the emergency function screen, but an
additional screen touch is required to send 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 Therapy status to
DISABLED 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.
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 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.
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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.
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.
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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.
• 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.
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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
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 and 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
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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).
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Lumax Technical Manual 23
s
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 1
Table 2
, respectively.
and
Table 1: Summary of Complications – Kronos LV-T
Category
Number
of
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
0.06
0.12
ICD Lead Related
Dislodgement 1 2.2% 1
Elevated Pacing
Threshold
1 2.2% 1
Total 2 4.4% 2
0.06
0.06
0.12
Unrelated to CRT-D or Leads
Hemathorax 1 2.2% 1
Total 1 2.2% 1
Overall
Complication Totals
3 6.7% 5
0.06
0.06
0.30
Number of Patients = 45, Number of Patient-Years = 16.8
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24 Lumax Technical Manual
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
of
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.
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Lumax Technical Manual 25
1.5.2.2 Tupos LV/ATx Study
NOTE:
The clinical study information included in this section and in
Section 1.6.2
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.
was performed with the Tupos LV/ATx CRT-D,
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.
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s
Complications and observations for the Tupos LV/ATx study
group are summarized in Table 3
and Table 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 20.30% 29 0.28
of
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
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Lumax Technical Manual 27
s
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
of
Patients
4 3.01% 4 0.04
1 0.75% 1 0.01
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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28 Lumax Technical Manual
For the Tupos LV/ATx study group, there were 210 observations
in 104 patients with cumulative implant duration of 1240.4 months
(101.9 patient years). 78.2% of the enrolled study patients have a
reported observation. The rate of observations per patient-year
was 2.06. Table 4
summarizes by category each type of
observation for the study group.
Table 4: Summary of Observations – Tupos LV/ATx
Number
Category
Hematoma 10 7.52% 10 0.10
Cardiac arrest 2 1.50% 2 0.02
Unable to implant
system
Total 13 9.77% 13 0.13
Dislodgement 1 0.75% 1 0.01
High threshold 1 0.75% 1 0.01
Total 2 1.50% 2 0.02
High threshold/No
capture
Total 1 0.75% 1 0.01
High threshold/
Intermittent
biventricular capture/
No capture
Diaphragmatic/
Intercostal stimulation
Total 30 22.56% 32 0.31
of
Patients
Procedure Related
1 0.75% 1 0.01
Atrial Lead Related
ICD Lead Related
1 0.75% 1 0.01
LV Lead Related
24 18.05% 24 0.24
8 6.02% 8 0.08
% of
Patients
Number
per patient-
year
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