BIOTRONIK Cardiac Airbag User manual

(Draft)
Cardiac Airbag /
Cardiac Airbag-T
Family of Implantable Cardioverter
Defibrillators and Software Cartridge for
TMS 1000PLUS and EPR 1000PLUS
Technical Manual

X-ray Identification
Cardiac Airbag/Cardiac Airbag-T
Implantable Cardioverter Defibrillator
Inside the housing, top left-hand side:
Year of manufacture
X-Ray identification
EI•
CAUTION
Federal (U.S.A.) law restricts this device to sale by, or on the
order of, a physician.
2003 BIOTRONIK, Inc., all rights reserved.

Cardiac Airbag Technical Manual i
Contents
1. General...........................................................................1
1.1 System Description....................................................1
1.2 Indications and Usage ...............................................2
1.3 Contraindications .......................................................2
1.4 Warnings and Precautions.........................................3
1.4.1 Sterilization, Storage, and Handling ..................3
1.4.2 Device Implantation and Programming..............4
1.4.3 Lead Evaluation and Connection.......................6
1.4.4 Follow-up Testing...............................................7
1.4.5 Pulse Generator Explant and Disposal..............8
1.4.6 Hospital and Medical Hazards ...........................9
1.4.7 Home and Occupational Hazards......................11
1.4.8 Cellular Phones..................................................11
1.4.9 Electronic Article Surveillance (EAS).................12
1.4.10 Home Appliances...............................................12
1.5 Adverse Events..........................................................13
1.5.1 Potential Adverse Events...................................13
1.5.2 Observed Adverse Events .................................14
1.6 Clinical Studies ..........................................................17
1.6.1 Patients Studied.................................................17
1.6.2 Methods .............................................................18
1.6.3 Results ...............................................................18
1.7 Patient Selection and Treatment ...............................20
1.7.1 Individualization of Treatment............................20
1.7.2 Specific Patient Populations ..............................20
1.8 Patient Counseling Information .................................20
1.9 Evaluating Prospective ICD Patients.........................21
2. Device Features ............................................................22
2.1 Sensing ......................................................................22
2.1.1 Ventricular Sensitivity Settings ..........................22
2.1.2 Minimum Ventricular Threshold .........................25
2.2 Ventricular Tachyarrhythmia Detection ......................25
2.2.1 VF Classifications ..............................................26
2.2.2 VT Interval Counters ..........................................26
2.2.3 VT Classification ................................................26
2.2.4 Onset and Stability .............................................27

ii Cardiac Airbag Technical Manual
2.3 Tachyarrhythmia Redetection ....................................28
2.3.1 VT Redetection ..................................................28
2.3.2 VF Redetection ..................................................28
2.3.3 Tachyarrhythmia Termination ............................28
2.4 Tachyarrhythmia Therapy ..........................................28
2.4.1 Shock Therapy...................................................29
2.5 Bradycardia Therapy .................................................31
2.5.1 Bradycardia Pacing Modes................................31
2.5.2 Basic Rate..........................................................31
2.5.3 Rate Adaptation .................................................31
2.5.4 Gain and Threshold ...........................................32
2.5.5 Rate Increase / Decrease ..................................32
2.5.6 Maximum Sensor Rate ......................................32
2.5.7 Pulse Amplitude .................................................32
2.5.8 Pulse Width........................................................33
2.5.9 Noise Response.................................................33
2.5.10 Post Shock Pacing.............................................33
2.6 Special Features ........................................................33
2.6.1 Home Monitoring (Cardiac Airbag-T Only) ........33
2.6.2 Real-time IEGM Transmission...........................37
2.6.3 Capacitor Reformation .......................................37
2.6.4 Patient and Implant Data ...................................38
2.6.5 System Status....................................................39
2.6.6 Holter Memory ...................................................40
2.6.7 Arrhythmia Induction Features...........................42
2.6.8 Manual Shock ....................................................43
2.6.9 Test Shock .........................................................43
3. Software Features.........................................................44
3.1 Follow-Up Assistant (FAST) Window.........................44
3.1.1 Interrogate ICD without Follow-up .....................45
3.2 Main Function Keys ...................................................45
3.3 Parameter Window ....................................................47
4. Sterilization and Storage..............................................50
5. Implant Procedure ........................................................52
5.1 Implant Preparation ...................................................52
5.2 Lead System Evaluation ............................................52
5.3 Opening the Sterile Container ...................................53
5.4 Pocket Preparation ....................................................53
5.5 Lead to Device Connection .......................................54

Cardiac Airbag Technical Manual iii
5.6 Blind Plug Connection ...............................................55
5.7 Program the ICD........................................................56
5.8 Implant the ICD..........................................................56
5.9 Suggested Cardiac Airbag Implant Procedure ..........57
6. Follow-up Procedures ..................................................68
6.1 General Considerations.............................................68
6.2 Suggested Cardiac Airbag Follow-Up Procedure......68
6.3 Longevity....................................................................74
6.3.1 Standard ERI Method ........................................74
6.3.2 Treated VF Episode ERI Method.......................76
6.4 Explantation ...............................................................78
7. Technical Specifications ..............................................80
Appendix A...........................................................................85

iv Cardiac Airbag Technical Manual
Cardiac Airbag Specifications
Battery Voltage: 6.3 Volts
Maximum Shock Energy: 30 joules
Defibrillation Lead Ports Two DF-1 (3.2 mm)
Pacing Lead Ports One IS-1 (3.2 mm)
Dimension: 55 x 67 x 13 mm
Volume: 39 cc
Mass: 73 g
Housing Material: Titanium
Header Material: Epoxy Resin
Sealing Plug Material: Silicone
Battery Composition Li / MnO2

Cardiac Airbag Technical Manual 1
1. General
1.1 System Description
The Cardiac Airbag family of Implantable Cardioverter
Defibrillators (ICDs) detects and treats ventricular
tachyarrhythmias as well as provides rate adaptive bradycardia
pacing support. The ICDs 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 Cardiac Airbag ICDs
are specifically designed to have reduced complexity for implant
and follow-up, yet provide essential therapies for conversion of
life threatening ventricular tachyarrhythmias.
There are 10 programmable parameters to simplify the implant
procedure, and detailed diagnostic information is stored for up to
10 ventricular tachycardia (VT) episodes and 3 treated
ventricular fibrillation (VF) episodes. There are 30 minutes of
single-channel IEGM storage available to record spontaneous
and induced ventricular tachyarrhythmias. The Cardiac Airbag is
restricted to storage of diagnostic information up to and including
3 treated ventricular fibrillation episodes.
The Cardiac Airbag ICDs provide therapy for ventricular
tachyarrhythmias with programmable defibrillation therapy. The
ICDs provide high energy biphasic shocks with the first shock
having with programmable energies of 20 or 30 joules and up to
8 shocks per VF episode. The remaining 7 shocks in the
therapy progression are pre-set at 30 joules.
The Cardiac Airbag family of ICDs includes the following
members:
•Cardiac Airbag provides therapies for ventricular
tachyarrhythmias and single chamber rate adaptive
bradycardia pacing support.
•Cardiac Airbag-T is identical to the Cardiac Airbag with
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.

2Cardiac Airbag Technical Manual
The Cardiac Airbag and Cardiac Airbag-T have two DF-1
defibrillation / cardioversion and 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 System. These external devices
include the TMS 1000
PLUS Tachyarrhythmia Monitoring System
and the EPR 1000
PLUS Programming and Monitoring System.
These programmers are used to interrogate and program the
ICDs. In addition, the programmer software is used to perform
the interrogation and programming of the ICDs during implant
and follow-up testing.
1.2 Indications and Usage
The Cardiac Airbag Implantable Cardioverter Defibrillators
(ICDs) are intended to provide ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmias.
1.3 Contraindications
Do not use the Cardiac Airbag Implantable Cardioverter
Defibrillators (ICDs) in patients:
•Whose ventricular tachyarrhythmias may have transient
or reversible causes including:
-acute myocardial infarction
-digitalis intoxication
-drowning
-electrocution
-electrolyte imbalance
-sepsis
-hypoxia
•Patients with incessant VT of VF
•Patients with unipolar pacemaker
•Patients whose only disorder is brady arrhythmia or
atrial arrhythmia

Cardiac Airbag Technical Manual 3
1.4 Warnings and Precautions
ATP (Anti-Tachycardia Pacing) – The Cardiac Airbag ICD
does not provide ATP therapy. Do not implant this ICD in
patients with documented ventricular tachycardias unless high
energy defibrillation is desired for treatment of the ventricular
arrhythmia.
MRI (Magnetic Resonance Imaging) - Do not expose a patient
dvertent arrhythmia
CD lead
ation Availability - Do not perform induction testing
program the VT/VF Detection and
in
1.4.1 Sterilization, Storage, and Handling
device’s
e-sterilize and re-implant explanted
to MRI device scanning. Strong magnetic fields may damage
the device and cause injury to the patient.
Electrical Isolation - To prevent ina
induction, electrically isolate the patient during the implant
procedure from potentially hazardous leakage currents.
Lead Systems - The use of another manufacturer’s I
system may cause potential adverse consequences such as
under sensing of cardiac activity and failure to deliver necessary
therapy.
Resuscit
unless an alternate source of patient defibrillation such as an
external defibrillator is readily available. In order to implant the
ICD system, it is necessary to induce and convert the patient’s
ventricular tachyarrhythmias.
Unwanted Shocks – Always
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.
Rate-Adaptive Pacing – Use rate-adaptive pacing with care
patients unable to tolerate increased pacing rates.
Device Packaging - Do not use the device if the
packaging is wet, punctured, opened or damaged because the
integrity of the sterile packaging may be compromised. Return
the device to BIOTRONIK.
Re-sterilization - Do not r
devices.

4Cardiac Airbag Technical Manual
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
ected
ing of the high voltage
Blind Plug - A blind plug must be inserted and firmly conn
into any unused header port to prevent chronic fluid influx and
possible shunting of high energy therapy.
Capacitor Reformation - Infrequent charg
capacitors may extend the charge times of the ICD. The
capacitors may be reformed manually, or the ICD may be
programmed to reform the capacitors automatically. For further
information, please refer to Section 2.6.3, Capacitor Reforming.
Connector Compatibility - ICD 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 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, tachyarrhythmia detection and therapy
will proceed until EOS is declared. Bradycardia functions are
still active at programmed values until the battery voltage drops
below 3.0 volts.

Cardiac Airbag Technical Manual 5
Magnets - Positioning of a magnet or the programming wand
over the ICD 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.
Pacemaker/ICD Interaction - In situations where an ICD and a
pacemaker are implanted in the same patient, interaction testing
should be completed. If the interaction between the ICD and the
pacemaker cannot be resolved through repositioning of the
leads or reprogramming of either the pacemaker or the ICD, the
pacemaker should not be implanted (or explanted if previously
implanted).
Programmed Parameters – Program the device parameters to
appropriate values based on the patient’s specific arrhythmias
and condition.
Programmers - Use only BIOTRONIK programmers to
communicate with the device (TMS 1000
PLUS, or
EPR 1000 PLUS).
Sealing Sy m
ste - Failure to properly insert the torque wrench
ld - Be aware that the changes in the
hocks may be withheld if
preparing a high energy shock the charge
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 Thresho
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 s
the ICD is already busy processing a manual command or the
Battery Status is low.
Charge Time - When
circuit stops charging the capacitors after 16 seconds, and
delivers the stored energy as shock therapy. After the device
reaches ERI the stored energy may be less than 30 joules per
shock.

6Cardiac Airbag Technical Manual
Shock Impedance - If the shock impedance is less than twenty-
five 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
twenty-five ohms. Damage to the device may result.
Programming Wand - Throughout the EP Test session, the
programming wand must be positioned and remain directly over
the device. If appropriate arrhythmia detection does not occur
shortly after induction, remove the programming wand from the
ICD and perform external defibrillation.
Data Transmission -Data collection and transmission may take
up to 30 seconds. The ICD cannot be reprogrammed during this
time even if the [Emergency] key is pressed. Remove the
programming wand immediately to restore the permanent
program.
EP Test Functions -Ensure that cardiac resuscitation
equipment is available during all EP Test Function operations.
Physicians should be trained and experienced in
tachyarrhythmia induction, conversion protocols, and have
adequate training and experience with this device prior to use.
Potential side effects include:
•Non-terminable arrhythmia’s that result in death
•Complications from hypoxia due to prolonged
arrhythmia’s
•Arrhythmia induction that requires cardioversion or
defibrillation
•Arrhythmia induction that requires pharmacologic
treatment, to which the patient could have an adverse
reaction
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.

Cardiac Airbag Technical Manual 7
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 system.
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.
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.

8Cardiac Airbag Technical Manual
Resuscitation Availability - Ensure that an external defibrillator
and medical personnel skilled in cardiopulmonary resuscitation
screen, but an additional
screen touch is required to send the safe program to the ICD.
re
by accidentally touching the
screen.
n. The ICD must be explanted prior to
d Shocks – Always program the therapy status to
ery of
device
(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. Pressing the “Safe Program”
key activates the emergency function
Date and Time Values - If date and time values are incorrect,
the system may, as a result, generate false system status
information for the implant.
Impedance Measurement - During the impedance
measurement with high stimulation amplitudes, nerve or skeletal
muscles may be briefly stimulated.
Threshold Test - A minimum 2:1 voltage safety margin should
be permanently programmed any time capture thresholds a
assessed. Monitor the ECG display closely with pacer-
dependent patients. The test should be terminated immediately
upon loss of capture.
Inadvertent Programming - The programmer utilizes a touch
sensitive screen for menu selections. Care must be used to
avoid inadvertent menu selection
1.4.5 Pulse Generator Explant and Disposal
Device Incineration – Never incinerate the ICD due to the
potential for explosio
cremation.
Explanted Devices – Return all explanted devices to
BIOTRONIK.
Unwante
DISABLED prior to handling the device to prevent the deliv
serious shocks to the patient or the person handling the
during the implant procedure.

Cardiac Airbag Technical Manual 9
1.4.6 Hospital and Medical Hazards
Electromagnetic interference (EMI) signals present in hospital
ible with this or any other ICD.
therapy disabled
l procedures. In
it
or may cause device malfunction
and medical environments may affect the function of any ICD or
pacemaker. The ICD is designed to selectively filter out EMI
noise. However, due to the variety of EMI signals, absolute
protection from EMI is not poss
The ICD system should have detection and
prior to performing any of the following medica
addition, the ICD should be checked after the procedures to
assure proper programming:
Diathermy - Diathermy therapy is not recommended for ICD
patients due to possible heating effects of the pulse generator
and at the implant site. If diathermy therapy must be used,
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 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)).

10 Cardiac Airbag Technical Manual
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 to confirm device status and proper
function.
Lithotripsy - Lithotripsy may damage the ICD. If lithotripsy must
be used, avoid focusing near the ICD 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.
Radio Frequency Ablation - Prior to performing an ablation
procedure, deactivate the ICD during the procedure. Avoid
applying ablation energy near the implanted lead system
whenever possible.

Cardiac Airbag Technical Manual 11
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 to return to its normal
mode of operation.
The following equipment (and similar devices) may affect normal
ICD operation: electric arc or resistance welders, electric melting
furna c es, r a dio/te l e vision and radar tra n smitte r s,
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 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, when the ICD is programmed to standard sensitivity.
Patients having an implanted BIOTRONIK ICD 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.

12 Cardiac Airbag Technical Manual
Based on results to date, adverse effects resulting from
interactions between cellular telephones and implanted ICDs
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, moving the telephone
away from the immediate vicinity of the ICD should restore
normal operation. A recommendation to address every specific
interaction of EMI with implanted ICDs 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 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 when they are placed in close proximity to the device.

Cardiac Airbag Technical Manual 13
1.5 Adverse Events
1.5.1 Potential Adverse Events
The following is a list of the potential risks that may occur with
this device:
•Acceleration of arrhythmias
•Air embolism
•Bleeding
•Chronic nerve damage
•Erosion
•Excessive fibrotic tissue growth
•Extrusion
•Fluid accumulation
•Formation of hematomas or cysts
•Inappropriate shocks
•Infection
•Keloid formation
•Lead abrasion and discontinuity
•Lead migration / dislodgment
•Myocardial damage
•Pneumothorax
•Shunting current or insulating myocardium during
defibrillation with internal or external paddles
•Potential mortality due to inability to defibrillate or pace
•Thromboemboli
•Venous occlusion
•Venous or cardiac perforation

14 Cardiac Airbag Technical Manual
Patients susceptible to frequent shocks despite antiarrhythmic
medical management may develop psychological intolerance to
an ICD system that may include the following:
•Dependency
•Depression
•Fear of premature battery depletion
•Fear of shocking while conscious
•Fear that shocking capability may be lost
•Imagined shocking (phantom shock)
There may be other risks associated with this device that are
currently unforeseeable.
1.5.2 Observed Adverse Events
A clinical study of the Phylax XM involved 155 devices implanted
in 154 patients with cumulative implant duration of 1286 months
(mean implant duration 8.3 months). This clinical study was
performed with the Phylax XM and Phylax 06 ICDs, which are
earlier versions of the Cardiac Airbag ICDs. The observed
adverse events are applicable because the Cardiac Airbag ICD
is a downsized version of the Phylax XM with rate adaptive
pacing capabilities.
NOTE:
The Phylax XM ICD is an earlier generation of BIOTRONIK
devices. The Cardiac Airbag family is based upon the
Phylax XM and other BIOTRONIK ICDs (i.e., Belos VR and
Belos VR-T).
There were a total of five deaths during the course of the trial;
none of the deaths were judged by the clinical study investigator
to be device related. Heart failure was a major factor in two
deaths. The other three deaths were related to renal failure,
lung disease, and septic shock secondary to an ischemic bowel,
respectively. All five of the deaths occurred more than one
month post implant.