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
6.
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
TM
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.
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.
Lumax Technical Manual 3
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%);
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
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
TM
Lead
TM
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
TM
Lead 6932
TM
TM
RV Lead 6936
TM
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:
Pneumothorax
Pocket erosion
Thromboembolism
Under sensing of intrinsic
signals
Venous occlusion
Venous or cardiac
perforation
18 Lumax Technical Manual
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
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 2
Table 3
, respectively.
and
Table 2: 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
Number of Patients = 45, Number of Patient-Years = 16.8
3 6.7% 5
0.06
0.06
0.30
20 Lumax Technical Manual
Table 3: 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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