Boston Scientific EMBLEM S-ICD User manual

PULSE GENERATOR USER'S MANUAL
EMBLEM™ S-ICD
Subcutaneous Implantable Cardioverter Debrillator
A209
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EMBLEM is a trademark of Boston Scientic.
This product may be protected by one or more patents. Patent information can be obtained at http://www.
bostonscientic.com/patents.
List of Acronyms
ATP Anti-tachycardia pacing
BOL Beginning of life
CPR Cardiopulmonary resuscitation
CRT Cardiac resynchronization therapy
DFT Debrillation threshold
EAS Electronic article surveillance
ECG Electrocardiogram
EGM Electrogram
EIT Electrode insertion tool
EMI Electromagnetic interference
EOL End of life
ERI Elective replacement indicator
ESWL Extracorporeal shock wave lithotripsy
HBOT Hyperbaric oxygen therapy
MRI Magnetic resonance imaging
NSR Normal sinus rhythm
PVC Premature ventricular contraction
S-ECG Subcutaneous electrocardiogram
S-ICD Subcutaneous implantable cardioverter debrillator
SVT Supraventricular tachycardia
TENS Transcutaneous electrical nerve stimulation
VF Ventricular brillation
VT Ventricular tachycardia
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Table of Contents
Description 1
Related Information 1
Intended Audience 1
Indications for Use 1
Contraindications 1
Warnings 1
General 1
Handling 2
Implantation 2
Post-Implant 3
Precautions 3
Clinical Considerations 3
Sterilization and Storage 4
Implantation 4
Device Programming 5
Environmental and Medical Therapy Hazards 6
Hospital and Medical Environments 6
Home and Occupational Environments 10
Follow-up Testing 12
Explant and Disposal 12
Supplemental Precautionary Information 12
Potential Adverse Events 13
Patient Screening 15
Collecting the Surface ECG 15
Evaluating the Surface ECG 17
Determining an Acceptable SenseVector 18
Operation 19
General 19
Modes of Operation 19
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Shelf Mode 19
Therapy On Mode 19
Therapy O Mode 19
Sensing Conguration and Gain Selection 20
Sensing and Tachyarrhythmia Detection 20
Detection Phase 20
Certication Phase 21
Decision Phase 21
Therapy Zones 21
Analysis in the Conditional Shock Zone 22
Charge Conrmation 23
Therapy Delivery 23
Smart Charge 23
Redetection 24
Shock Waveform and Polarity 24
Post-Shock Bradycardia PacingTherapy 24
Manual and Rescue Shock Delivery 24
Additional Features of the S-ICD System 25
Auto Capacitor Reformation 25
InternalWarning System – Beeper Control 25
Arrhythmia Induction 25
System Diagnostics 26
Subcutaneous Electrode Impedance 26
Device Integrity Check 26
Battery Performance Monitoring System 26
Storing and Analyzing Data 27
Treated Episodes 27
Untreated Episodes 27
Captured S-ECG 27
S-ECG Rhythm Strip Markers 28
Patient Data 29
S-ICD System Magnet Use 30
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Magnet use for patients with deep implant placement 31
Magnet Response and Pulse Generator Mode 32
Bidirectional Torque Wrench 33
Using the EMBLEM S-ICD Pulse Generator 33
Items Included in Package 33
Implanting the S-ICD System 33
Check Equipment 34
Interrogate and Check the Pulse Generator 35
Creating the Device Pocket 35
Implanting the EMBLEM S-ICD Subcutaneous Electrode 36
Connecting the Subcutaneous Electrode to the Device 39
Setting up the EMBLEM S-ICD Pulse Generator using the Model 3200 S-ICD Programmer 43
Debrillation Testing 44
Complete and Return the Implantation Form 45
Patient Counseling Information 46
Patient Guide 46
Post Implant Follow-Up Procedures 47
Explantation 48
Loosening Stuck Setscrews 49
Communication Compliance 50
Radio and Telecommunications Terminal Equipment (RTTE) 50
Additional Information 50
Product Reliability 50
Pulse Generator Longevity 51
Specications 52
X-ray Identier 52
Denitions of Package Label Symbols 59
S-ICD System and Pacemaker Interaction 61
Warranty Information 62
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Versión obsoleta. No utilizar.
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1
Description
The EMBLEM™S-ICD pulse generator (the“device”) is a component of the Boston Scientic S-ICD System, which is prescribed
for patients when cardiac arrhythmia management is warranted.The pulse generator accepts one EMBLEM S-ICD
subcutaneous electrode with an SQ-1 S-ICD connector.1The EMBLEM S-ICD pulse generator is also compatible with the
Cameron Health Model 3010 Q-TRAK subcutaneous electrode.
The pulse generator and subcutaneous electrode constitute the implantable portion of the S-ICD System. The pulse generator
can be used only with the EMBLEM S-ICD programmer Model 3200 and Model 3203 telemetry wand.
Related Information
For additional information about other components of the S-ICD System, refer to the following:
• EMBLEM S-ICD Subcutaneous Electrode User’s Manual
• EMBLEM S-ICD Subcutaneous Electrode InsertionTool User’s Manual
• EMBLEM S-ICD Programmer User’s Manual
Intended Audience
This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.
Indications for Use
The S-ICD System is intended to provide debrillation therapy for the treatment of life-threatening ventricular
tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous,
frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Contraindications
Unipolar pacing and impedance-based features are contraindicated for use with the S-ICD System.
Warnings
General
• Labeling knowledge. Read this manual thoroughly before using the S-ICD System to avoid damage to
the pulse generator and/or subcutaneous electrode. Such damage can result in patient injury or death.
1SQ-1 is a non-standard connector unique to the S-ICD System.
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2
• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and/or lead to device failure which,
in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also
create a risk of contamination of the device and/or cause patient infection or cross-infection, including,
but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness, or death of the patient.
• Component Compatibility. All Boston Scientic S-ICD implantable components are designed for
use with the Boston Scientic or Cameron Health S-ICD System only. Connection of any S-ICD System
components to a non-compatible component will result in failure to deliver life-saving debrillation
therapy.
• Backup debrillation protection. Always have external debrillation equipment and medical
personnel skilled in CPR available during implant and follow-up testing. If not terminated in a timely
fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.
• Pulse generator interaction. Using multiple pulse generators could cause pulse generator
interaction, resulting in patient injury or a lack of therapy delivery.Test each system individually and
in combination to help prevent undesirable interactions. Refer to the S-ICD System and Pacemaker
Interaction section on page 61 of this manual for more information.
Handling
• Proper Handling. Handle the components of the S-ICD System with care at all times and maintain
proper sterile technique. Failure to do so may lead to injury, illness, or death of the patient.
• Do not damage components. Do not modify, cut, kink, crush, stretch or otherwise damage any
component of the S-ICD System. Impairment to the S-ICD System may result in an inappropriate shock
or failure to deliver therapy to the patient.
• Handling the subcutaneous electrode. Use caution handling the subcutaneous electrode connector.
Do not directly contact the connector with any surgical instruments such as forceps, hemostats, or
clamps.This could damage the connector. A damaged connector may result in compromised sealing
integrity, possibly leading to compromised sensing, loss of therapy, or inappropriate therapy.
Implantation
• System dislodgement. Use appropriate anchoring techniques as described in the implant procedure
to prevent S-ICD System dislodgement and/or migration. Dislodgement and/or migration of the S-ICD
System may result in an inappropriate shock or failure to deliver therapy to the patient.
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3
Post-Implant
• Magnet Response. Use caution when placing a magnet over the S-ICD pulse generator because it
suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia
detection and therapy response.
• Magnet response with deep implant placement. In patients with a deep implant placement
(greater distance between the magnet and the pulse generator) magnet application may fail to elicit
the magnet response. In this case the magnet cannot be used to inhibit therapy.
• Diathermy. Do not expose a patient with an implanted S-ICD System to diathermy. The interaction
of diathermy therapy with an implanted S-ICD pulse generator or electrode can damage the pulse
generator and cause patient injury.
• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning. Strong
magnetic elds may damage the pulse generator and/or subcutaneous electrode, possibly resulting in
injury to or death of the patient.
• Protected environments. Advise patients to seek medical guidance before entering environments
that could adversely aect the operation of the active implantable medical device, including areas
protected by a warning notice that prevents entry by patients who have a pulse generator.
• Sensitivity settings and EMI. The pulse generator may be more susceptible to low frequency
electromagnetic interference at induced signals greater than 80 uV. Oversensing of noise due to this
increased susceptibility could lead to inappropriate shocks and should be taken into consideration
when determining the follow-up schedule for patients exposed to low frequency electromagnetic
interference.The most common source of electromagnetic interference in this frequency range is the
power system for some European trains which operate at 16.6 Hz. Particular attention should be given
to patients with occupational exposure to these types of systems.
Precautions
Clinical Considerations
• Longevity. Battery depletion will eventually cause the S-ICD pulse generator to stop functioning.
Debrillation and excessive numbers of charging cycles shorten the battery longevity.
• Pediatric Use. The S-ICD System has not been evaluated for pediatric use.
• Available Therapies. The S-ICD System does not provide long-term bradycardia pacing, cardiac
resynchronization therapy (CRT) or anti-tachycardia pacing (ATP).
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4
Sterilization and Storage
• If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before
nal packaging.When the pulse generator and/or subcutaneous electrode is received, it is sterile
provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged,
return the pulse generator and/or subcutaneous electrode to Boston Scientic.
• If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf
package. Do not implant a device which has been dropped from a height of more than 24 inches (61 cm)
while within its intact shelf package. Sterility, integrity and/or function cannot be guaranteed under
these conditions and the device should be returned to Boston Scientic for inspection.
• Use by date. Implant the pulse generator and/or subcutaneous electrode before or on the USE BY date
on the package label because this date reects a validated shelf life. For example, if the date is January
1, do not implant on or after January 2.
• Device storage. Store the pulse generator in a clean area away from magnets, kits containing magnets,
and sources of EMI to avoid device damage.
• Storage temperature and equilibration. Recommended storage temperatures are 0°C–50°C
(32°F–122°F). Allow the device to reach a proper temperature before using telemetry communication
capabilities, programming or implanting the device because temperature extremes may aect initial
device function.
Implantation
• Avoid shock at implant. Verify the device is in Shelf mode or Therapy O to prevent the delivery of
unwanted shocks to the patient or the person handling the device during the implant procedure.
• Evaluate patient for surgery. There may be additional factors regarding the patient’s overall health
and medical condition that, while not related to device function or purpose, could render the patient
a poor candidate for implantation of this system. Cardiac health advocacy groups may have published
guidelines that may be helpful in conducting this evaluation.
• Creating the subcutaneous tunnel. Use only the electrode insertion tool to create the subcutaneous
tunnel when implanting and positioning the subcutaneous electrode.
• Suture location. Suture only those areas indicated in the implant instructions.
• Do not suture directly over subcutaneous electrode body. Do not suture directly over the
subcutaneous electrode body, as this may cause structural damage. Use the suture sleeve to prevent
subcutaneous electrode movement.
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5
• Do not bend the subcutaneous electrode near the electrode-header interface. Insert the
subcutaneous electrode connector straight into the pulse generator header port. Do not bend the
subcutaneous electrode near the subcutaneous electrode-header interface. Improper insertion can
cause insulation or connector damage.
• Subcutaneous Electrode connections. Do not insert the subcutaneous electrode into the pulse
generator connector port without taking the following precautions to ensure proper insertion:
› Insert the torque wrench into the preslit depression of the seal plug before inserting the subcutaneous
electrode connector into the port, to release any trapped uid or air.
› Visually verify that the setscrew is suciently retracted to allow insertion. Use the torque wrench to loosen
the setscrew if necessary.
› Fully insert the subcutaneous electrode connector into the port and then tighten the setscrew onto the
connector.
• Sternal wires. When implanting the S-ICD system in a patient with sternal wires, ensure that there
is no contact between the sternal wires and the distal and proximal sense electrodes (for example,
by using uoroscopy). Compromised sensing can occur if metal-to-metal contact occurs between a
sense electrode and a sternal wire. If necessary, re-tunnel the electrode to ensure sucient separation
between the sense electrodes and the sternal wires.
• Replacement device. Implanting a replacement device in a subcutaneous pocket that previously
housed a larger device may result in pocket air entrapment, migration, erosion, or insucient grounding
between the device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility
of pocket air entrapment and insucient grounding. Suturing the device in place reduces the possibility
of migration and erosion.
• Telemetry wand. The wand is a non-sterile device. Do not sterilize the wand or programmer. The wand
must be contained in a sterile barrier before use in the sterile eld.
Device Programming
• Device communication. Use only the designated programmer and software application to
communicate with the S-ICD pulse generator.
• Sensing adjustment. Following any sensing parameter adjustment or any modication of the
subcutaneous electrode, always verify appropriate sensing.
• Patients hear tones coming from their device. Patients should be advised to contact their
physician immediately whenever they hear beeping tones coming from their device.
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6
• Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and
programmed parameters are appropriate for patients with SVTs because SVTs can initiate unwanted
device therapy.
Environmental and Medical Therapy Hazards
• Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI because EMI
may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy. Moving
away from the source of the EMI or turning o the source usually allows the pulse generator to return to
normal operation. Examples of potential EMI sources are:
› Electrical power sources, arc welding or resistance welding equipment, and robotic jacks
› High voltage power distribution lines
› Electrical smelting furnaces
› Large RF transmitters such as radar
› Radio transmitters, including those used to control toys
› Electronic surveillance (antitheft) devices
› An alternator on a car that is running
› Medical treatments and diagnostic tests in which an electrical current is passed through the body, such
as TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography, or nerve
conduction studies
› Any externally applied device that uses an automatic lead detection alarm system (e.g., an EKG machine)
Hospital and Medical Environments
• External debrillation. External debrillation or cardioversion can damage the pulse generator
or subcutaneous electrode. To help prevent damage to implanted system components, consider the
following:
› Avoid placing a pad (or paddle) directly over the pulse generator or subcutaneous electrode. Position the
pads (or paddles) as far from the implanted system components as possible.
› Set energy output of external debrillation equipment as low as clinically acceptable.
› Following external cardioversion or debrillation, verify pulse generator function ("Post-Therapy Pulse
Generator Follow-Up" on page 12).
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7
• Cardiopulmonary resuscitation. Cardiopulmonary resuscitation (CPR) may temporarily interfere
with sensing and may cause delay of therapy.
• Electrical interference. Electrical interference or“noise”from devices such as electrocautery and
monitoring equipment may interfere with establishing or maintaining telemetry for interrogating
or programming the device. In the presence of such interference, move the programmer away from
electrical devices, and ensure that the wand cord and cables are not crossing one another.
• Ionizing Radiation. It is not possible to specify a safe radiation dosage or guarantee proper pulse
generator function following exposure to ionizing radiation. Multiple factors collectively determine the
impact of radiation therapy on an implanted pulse generator, including proximity of the pulse generator
to the radiation beam, type and energy level of the radiation beam, dose rate, total dose delivered over
the life of the pulse generator, and shielding of the pulse generator. The impact of ionizing radiation will
also vary from one pulse generator to another and may range from no changes in function to a loss of
therapy.
Sources of ionizing radiation vary signicantly in their potential impact on an implanted pulse
generator. Several therapeutic radiation sources are capable of interfering with or damaging an
implanted pulse generator, including those used for the treatment of cancer, such as radioactive cobalt,
linear accelerators, radioactive seeds, and betatrons.
Prior to a course of therapeutic radiation treatment, the patient’s radiation oncologist and cardiologist or
electrophysiologist should consider all patient management options, including increased follow-up and
device replacement. Other considerations include:
› Shield the Pulse Generator with a radiation-resistant material, regardless of the distance between the Pulse
Generator and the radiation beam.
› Determining the appropriate level of patient monitoring during treatment.
Evaluate pulse generator operation during and following the course of radiation treatment to exercise
as much device functionality as possible ("Post-Therapy Pulse Generator Follow-Up" on page 12). The
extent, timing, and frequency of this evaluation relative to the radiation therapy regimen are dependent
upon current patient health, and therefore should be determined by the attending cardiologist or
electrophysiologist.
Pulse generator diagnostics are performed automatically once per hour, so pulse generator evaluation
should not be concluded until pulse generator diagnostics have been updated and reviewed (at least
one hour after radiation exposure).The eects of radiation exposure on the implanted pulse generator
may remain undetected until some time following exposure. For this reason, continue to monitor
pulse generator function closely and use caution when programming a feature in the weeks or months
following radiation therapy.
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8
• Electrocautery and Radio Frequency (RF) Ablation. Electrocautery and RF ablation may induce
ventricular arrhythmias and/or brillation, and may cause inappropriate shocks and inhibition of
post-shock pacing. Additionally, exercise caution when performing any other type of cardiac ablation
procedure in patients with implanted devices. If electrocautery or RF ablation is medically necessary,
observe the following to minimize risk to the patient and device:
› Program the pulse generator toTherapy O mode.
› Have external debrillation equipment available.
› Avoid direct contact between the electrocautery equipment or ablation catheters and the pulse generator
and subcutaneous electrode.
› Keep the path of the electrical current as far away as possible from the pulse generator and subcutaneous
electrode.
› If RF ablation and/or electrocautery is performed on tissue near the device or subcutaneous electrode,
verify pulse generator function ("Post-Therapy Pulse Generator Follow-Up" on page 12).
› For electrocautery, use a bipolar electrocautery system where possible and use short, intermittent, and
irregular bursts at the lowest feasible energy levels.
When the procedure is nished, return the pulse generator toTherapy On mode.
• Lithotripsy. Extracorporeal shock wave lithotripsy (ESWL) may cause electromagnetic interference
with or damage to the pulse generator. If ESWL is medically necessary, consider the following to
minimize the potential for encountering interaction:
› Avoid focusing the lithotripsy beam near the pulse generator implant site.
› Program the pulse generator toTherapy O mode to prevent inappropriate shocks.
• Ultrasound energy. Therapeutic ultrasound (e.g., lithotripsy) energy may damage the pulse
generator. If therapeutic ultrasound energy must be used, avoid focusing near the pulse generator site.
Diagnostic ultrasound (e.g., echocardiography) is not known to be harmful to the pulse generator.
• Radio frequency (RF) interference. RF signals from devices that operate at frequencies near that of
the pulse generator may interrupt telemetry while interrogating or programming the pulse generator.
This RF interference can be reduced by increasing the distance between the interfering device and the
programmer and pulse generator.
• Conducted electrical current. Any medical equipment, treatment, therapy, or diagnostic test
that introduces electrical current into the patient has the potential to interfere with pulse generator
function. Medical therapies, treatments, and diagnostic tests that use conducted electrical current (e.g.,
TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography, or nerve
conduction studies) may interfere with or damage the pulse generator. Program the device toTherapy
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9
O mode prior to the treatment, and monitor device performance during the treatment. After the
treatment, verify pulse generator function ("Post-Therapy Pulse Generator Follow-Up" on page 12).
• Transcutaneous Electrical Nerve Stimulation (TENS). TENS involves passing electrical current
through the body, and may interfere with pulse generator function. If TENS is medically necessary,
evaluate theTENS therapy settings for compatibility with the pulse generator. The following guidelines
may reduce the likelihood of interaction:
› Place the TENS electrodes as close together and as far away from the pulse generator and subcutaneous
electrode as possible.
› Use the lowest clinically-appropriate TENS energy output.
› Consider cardiac monitoring during TENS use.
Additional steps can be taken to help reduce interference during in-clinic use of TENS:
› If interference is suspected during in-clinic use, turn o the TENS unit.
› Do not change TENS settings until you have veried that the new settings do not interfere with pulse
generator function.
If TENS is medically necessary outside the clinical setting (at-home use), provide patients with the
following instructions:
› Do not change the TENS settings or electrode positions unless instructed to do so.
› End each TENS session by turning o the unit before removing the electrodes.
› If the patient receives a shock duringTENS use, they should turn o the TENS unit and contact their
physician.
Follow these steps to use the programmer to evaluate pulse generator function during TENS use:
1. Program the pulse generator toTherapy O mode.
2. Observe real-time S-ECGs at prescribedTENS output settings, noting when appropriate sensing or
interference occurs.
3. When nished, turn o theTENS unit and reprogram the pulse generator to Therapy On mode.
You should also perform a thorough follow-up evaluation of the pulse generator followingTENS, to
ensure that device function has not been compromised ("Post Therapy Pulse Generator Follow-Up" on
page 12).
For additional information, contact Boston Scientic using the information on the back cover.
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10
Home and Occupational Environments
• Home appliances. Home appliances that are in good working order and properly grounded do not
usually produce enough EMI to interfere with pulse generator operation.There have been reports of
pulse generator disturbances caused by electric hand tools or electric razors used directly over the pulse
generator implant site.
• Electronic Article Surveillance (EAS) and Security Systems. Advise patients to avoid lingering near
or leaning against antitheft and security gates or tag readers that include radio frequency identication
(RFID) equipment.These systems may be found at the entrances and exits of stores, in public libraries,
and in point-of-entry access control systems.These systems are unlikely to aect cardiac device function
when patients walk through them at a normal pace. If the patient is near an electronic antitheft,
security, or entry control system and experiences symptoms, they should promptly move away from
nearby equipment and inform their doctor.
• Cellular phones. Advise patients to hold cellular phones to the ear opposite the side of the implanted
device. Patients should not carry a cellular phone that is turned on in a breast pocket or on a belt within
15 cm (6 inches) of the implanted device since some cellular phones may cause the pulse generator to
deliver inappropriate therapy or inhibit appropriate therapy.
• Magnetic elds. Advise patients that extended exposure to strong (greater than 10 gauss or 1 mTesla)
magnetic elds may suspend arrhythmia detection. Examples of magnetic sources include:
› Industrial transformers and motors
› MRI scanners
› Large stereo speakers
› Telephone receivers if held within 1.27 cm (0.5 inches) of the pulse generator
› Magnetic wands such as those used for airport security and in the Bingo game
• Elevated Pressures. The International Standards Organization (ISO) has not approved a standardized
pressure test for implantable pulse generators that experience hyperbaric oxygen therapy (HBOT) or
SCUBA diving. However, Boston Scientic developed a test protocol to evaluate device performance
upon exposure to elevated atmospheric pressures.The following summary of pressure testing should
not be viewed as and is not an endorsement of HBOT or SCUBA diving.
Elevated pressures due to HBOT or SCUBA diving may damage the pulse generator. During laboratory
testing, all pulse generators in the test sample functioned as designed when exposed to more than
300 cycles at a pressure up to 3.0 ATA. Laboratory testing did not characterize the impact of elevated
pressure on pulse generator performance or physiological response while implanted in a human body.
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11
Pressure for each test cycle began at ambient/room pressure, increased to a high pressure level,
and then returned to ambient pressure. Although dwell time (the amount of time under elevated
pressure) may have an impact on human physiology, testing indicated it did not impact pulse generator
performance. Pressure value equivalencies are provided below (Table 1 on page 11).
Table 1: Pressure Value Equivalencies
Pressure value equivalencies
Atmospheres Absolute 3.0 ATA
Sea water deptha20 m (65 ft)
Pressure, absolute 42.7 psia
Pressure, gaugeb28.0 psig
Bar 2.9
kPa Absolute 290
aAll pressures were derived assuming sea water density of 1030 kg/m3.
bPressure as read on a gauge or dial (psia = psig + 14.7 psi).
Prior to SCUBA diving or starting an HBOT program, the patient’s attending cardiologist or
electrophysiologist should be consulted to fully understand the potential consequences relative to the
patient’s specic health condition. A Dive Medicine Specialist may also be consulted prior to SCUBA
diving.
More frequent device follow-up may be warranted in conjunction with HBOT or SCUBA diving. Evaluate
pulse generator operation following high pressure exposure ("Post-Therapy Pulse Generator Follow-Up"
on page 12). The extent, timing, and frequency of this evaluation relative to the high pressure
exposure are dependent upon current patient health, and should be determined by the attending
cardiologist or electrophysiologist. If you have additional questions, or would like more detail regarding
the test protocol or test results specic to HBOT or SCUBA diving, contact Boston Scientic using the
information on the back cover.
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12
Follow-up Testing
• Low shock impedance. A reported shock impedance value of less than 25 ohms from a delivered
shock could indicate a problem with the device.The delivered shock may have been compromised, and/
or any future therapy from the device may be compromised. If a reported impedance value of less than
25 ohms is observed, correct functioning of the device should be veried.
• Conversion testing. SuccessfulVF or VT conversion during arrhythmia conversion testing is no
assurance that conversion will occur post-operatively. Be aware that changes in the patient’s condition,
drug regimen, and other factors may change the DFT, which may result in nonconversion of the
arrhythmia post-operatively. Verify with a conversion test that the patient’s tachyarrhythmias can
be detected and terminated by the pulse generator system if the patient’s status has changed or
parameters have been reprogrammed.
• Follow-up considerations for patients leaving the country. Pulse generator follow-up
considerations should be made in advance for patients who plan to travel or relocate post-implant
to a country other than the country in which their device was implanted. Regulatory approval status
for devices and associated programmer software congurations varies by country; certain countries
may not have approval or capability to follow specic products. Contact Boston Scientic, using the
information on the back cover, for help in determining feasibility of device follow-up in the patient’s
destination country.
Explant and Disposal
• Device handling at explant. Before explanting, cleaning, or shipping the device, complete the
following actions to prevent unwanted shocks, overwriting of important therapy history data, and
audible tones:
› Program the pulse generator toTherapy O mode
› If ERI or EOL has been reached, disable the beeper.
› Clean and disinfect the device using standard biohazard handling techniques.
• Incineration. Be sure that the pulse generator is removed before cremation. Cremation and
incineration temperatures might cause the pulse generator to explode.
Supplemental Precautionary Information
• Post-Therapy Pulse Generator Follow-Up. Following any surgery or medical procedure with the
potential to aect pulse generator function, you should perform a thorough follow-up, which may
include the following:
› Interrogating the pulse generator with a programmer
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13
› Reviewing stored events, fault codes, and real-time S-ECGs prior to saving all patient data
› Testing the subcutaneous electrode impedance
› Verifying battery status
› Printing any desired reports
› Verifying the appropriate nal programming prior to allowing the patient to leave the clinic
› Ending session
Potential Adverse Events
Potential adverse events related to implantation of the S-ICD System may include, but are not limited to, the following:
• Acceleration/induction of atrial or ventricular arrhythmia
• Adverse reaction to induction testing
• Allergic/adverse reaction to system or medication
• Bleeding
• Conductor fracture
• Cyst formation
• Death
• Delayed therapy delivery
• Discomfort or prolonged healing of incision
• Electrode deformation and/or breakage
• Electrode insulation failure
• Erosion/extrusion
• Failure to deliver therapy
• Fever
• Hematoma/seroma
• Hemothorax
• Improper electrode connection to the device
• Inability to communicate with the device
• Inability to debrillate or pace
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14
• Inappropriate post shock pacing
• Inappropriate shock delivery
• Infection
• Keloid formation
• Migration or dislodgement
• Muscle/nerve stimulation
• Nerve damage
• Pneumothorax
• Post-shock/post-pace discomfort
• Premature battery depletion
• Random component failures
• Stroke
• Subcutaneous emphysema
• Surgical revision or replacement of the system
• Syncope
• Tissue redness, irritation, numbness or necrosis
If any adverse events occur, invasive corrective action and/or S-ICD System modication or removal may be required.
Patients who receive an S-ICD System may develop psychological disorders that include, but are not limited to, the following:
• Depression/anxiety
• Fear of device malfunction
• Fear of shocks
• Phantom shocks
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