Boston Scientific EMBLEM S-ICD User manual

USER’S MANUAL
EMBLEM™S-ICD
Subcutaneous Electrode
REF 3401

The following are trademarks of Boston Scientific Corporation or its affiliates:
EMBLEM and IMAGEREADY.
This product may be protected by one or more patents. Patent information can
be obtained at http://www.bostonscientific.com/patents.

Table of Contents
INTRODUCTION ...............................................................................1
Description .....................................................................................1
Related Information ..........................................................................1
MR Conditional System Information ..................................................... 1
Indications for Use ........................................................................... 2
Contraindications .............................................................................2
Warnings........................................................................................3
Precautions ....................................................................................4
Potential Adverse Events................................................................... 6
USING THE S-ICD SYSTEM ................................................................ 7
Items Included in Package .................................................................7
IMPLANTING THE S-ICD SYSTEM.......................................................8
Creating the Device Pocket ................................................................9
Implanting the EMBLEM S-ICD Subcutaneous Electrode.......................... 9
POST-IMPLANT .............................................................................. 13
Post Implant Follow-Up Procedures ................................................... 13
Explantation.................................................................................. 13
SPECIFICATIONS ........................................................................... 15
EMBLEM S-ICD Subcutaneous Electrode Diagram ............................... 15
EMBLEM S-ICD Subcutaneous Electrode Specifications ........................ 15
Definitions of Package Label Symbols ................................................ 16
WARRANTY................................................................................... 17
Warranty Information ...................................................................... 17

1
INTRODUCTION
Description
The EMBLEM™S-ICD subcutaneous electrode (the “subcutaneous electrode”)
is a component of the Boston Scientific S-ICD System, which is prescribed for
patients when cardiac arrhythmia management is warranted. The S-ICD
System detects cardiac activity and provides defibrillation therapy. The
subcutaneous electrode is implanted with the distal portion positioned parallel
to the left sternal border and the proximal end connected to an EMBLEM S-ICD
System pulse generator via an SQ-1 S-ICD connector1. The subcutaneous
electrode is also compatible with the Cameron Health Model 1010 SQ-RX
pulse generator.
The subcutaneous electrode includes one high voltage shock electrode coil for
the purpose of providing defibrillation energy. The shock electrode is
constructed using multifilars of metallic wire formed into a defibrillation coil 8
cm in length. Defibrillation is delivered between the coil on the subcutaneous
electrode and the electrically conductive pulse generator case.
The subcutaneous electrode also includes proximal and distal sensing ring
electrodes. These sense electrodes are constructed using metallic tubing
mechanically affixed to the body of the subcutaneous electrode. Sensing
occurs between the two electrically conductive rings on the subcutaneous
electrode or between either of the rings on the subcutaneous electrode and the
electrically conductive pulse generator case.
Related Information
For additional information about other components of the S-ICD System, refer
to the following:
• EMBLEM S-ICD Pulse Generator User’s Manual
• EMBLEM S-ICD Subcutaneous Electrode Insertion Tool User’s Manual
• EMBLEM S-ICD Programmer User’s Manual
Refer to the ImageReady MR Conditional S-ICD System MRI Technical Guide
(hereafter referred to as the MRI Technical Guide) for information about MRI
scanning.
INTENDED AUDIENCE
This literature is intended for use by professionals trained or experienced in
device implant and/or follow-up procedures.
MR Conditional System Information
A Boston Scientific/Cameron Health subcutaneous electrode can be used as
part of the ImageReady S-ICD System when connected to a Boston Scientific
MR Conditional S-ICD pulse generator. Patients with an MR Conditional S-ICD
System may be eligible to undergo MRI scans if performed when all Conditions
1. SQ-1 is a non-standard connector unique to the S-ICD System.

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of Use, as defined in the MRI Technical Guide, are met. Components required
for MR Conditional status include specific models of Boston Scientific S-ICD
pulse generator, electrodes, and accessories; the Programmer; and
Programmer Software Application. For the model numbers of MR Conditional
S-ICD pulse generator and components, as well as a complete description of
the ImageReady S-ICD System, refer to the MRI Technical Guide.
Refer to the MRI Technical Guide for a comprehensive list of Warnings,
Precautions, and Conditions of Use that are applicable to MRI scanning of
patients implanted with an ImageReady S-ICD System.
Implant-related MRI Conditions of Use
The following subset of the MRI Conditions of Use pertains to implantation and
is included as a guide to ensure implantation of a complete ImageReady S-ICD
System. For a full list of Conditions of Use, and potential adverse events
applicable when the Conditions of Use are met or not met, refer to the MRI
Technical Guide. All items on the full list of Conditions of Use must be met in
order for an MRI scan to be considered MR Conditional.
• Patient is implanted with an ImageReady S-ICD System
• No other active or abandoned implanted devices, components, or
accessories present such as lead adaptors, extenders, leads, or pulse
generators
• Patient is judged to be clinically capable of tolerating no Tachycardia
protection for the entire duration in which the pulse generator is in MRI
Protection Mode
• At least six (6) weeks have elapsed since implantation and/or any
electrode revision or surgical modification of the ImageReady S-ICD
System
• No evidence of a fractured electrode or compromised pulse generator-
electrode system integrity
NOTE: Other implanted devices or patient conditions may cause a patient to
be ineligible for an MRI scan, independent of the status of the patient’s
ImageReady S-ICD System.
Indications for Use
The S-ICD System is intended to provide defibrillation 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
antitachycardia pacing.
Contraindications
Unipolar pacing and impedance-based features are contraindicated for use
with the S-ICD System.

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WARNINGS
NOTE: Before using the S-ICD System, read and follow all warnings and
precautions provided in the EMBLEM S-ICD Pulse Generator User’s Manual.
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.
•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 Scientific S-ICD implantable
components are designed for use with the Boston Scientific 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
defibrillation therapy.
•Backup defibrillation protection. Always have external defibrillation
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.
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.

4
•Do not implant in MRI site Zone III. Implant of the system cannot be
performed in an MRI site Zone III (and higher) as defined by the American
College of Radiology Guidance Document for Safe MR Practices2. Some
of the accessories packaged with pulse generators and electrodes,
including the torque wrench and electrode insertion tool, are not MR
Conditional and should not be brought into the MRI scanner room, the
control room, or the MRI site Zone III or IV areas.
Post-Implant
•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. Unless all of the MRI
Conditions of Use (as described in the MRI Technical Guide) are met, MRI
scanning of the patient does not meet MR Conditional requirements for the
implanted system, and significant harm to or death of the patient and/or
damage to the implanted system may result.
Refer to the MRI Technical Guide for potential adverse events applicable
when Conditions of Use are met or not met, as well as for a complete list of
MRI-related Warnings and Precautions.
PRECAUTIONS
Clinical Considerations
•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
antitachycardia pacing (ATP).
Sterilization and Storage
•If package is damaged. The blister trays and contents are sterilized with
ethylene oxide gas before final 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
Scientific.
•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
reflects a validated shelf life. For example, if the date is January 1, do not
implant on or after January 2.
•Storage temperature. The recommended storage temperature range is
-18°C to +55°C (0°F to +131°F).
2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007

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Implantation
•Creating the subcutaneous tunnel. Use only the electrode insertion tool
to create the subcutaneous tunnel when implanting and positioning the
subcutaneous electrode. Avoid tunneling close to any other
subcutaneously implanted medical devices or components, for example an
implantable insulin pump, drug pump, or ventricular assist device.
•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.
•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.
•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 fluoroscopy).
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 sufficient separation between the sense electrodes and the
sternal wires.
Hospital and Medical Environments
•External defibrillation. External defibrillation 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 defibrillation equipment as low as
clinically acceptable.
• Following external cardioversion or defibrillation, verify pulse
generator function (see the appropriate S-ICD pulse generator
manual for suggested post-therapy follow-up actions).
•Cardiopulmonary resuscitation. Cardiopulmonary resuscitation (CPR)
may temporarily interfere with sensing and may cause delay of therapy.
•Electrocautery and RF ablation. Electrocautery and RF ablation may
induce ventricular arrhythmias and/or fibrillation, 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:

6
• Program the pulse generator to Therapy Off mode.
• Have external defibrillation 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
(see the appropriate S-ICD pulse generator manual for suggested
post-therapy follow-up actions).
• 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 finished, return the pulse generator to Therapy On
mode.
Explant and Disposal
•Handling at explant. Clean and disinfect implanted components using
standard biohazard handling techniques.
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

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• Inability to communicate with the device
• Inability to defibrillate or pace
• 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
For a list of potential adverse events associated with MRI scanning, refer to the
MRI Technical Guide.
If any adverse events occur, invasive corrective action and/or S-ICD System
modification 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
USING THE S-ICD SYSTEM
Items Included in Package
The subcutaneous electrode has been sterilized with ethylene oxide gas and is
packaged in a sterile container that is suitable for use in the operating field.
Store in a clean, dry area. The following items are included with the
subcutaneous electrode:
• Two silicone suture sleeves
• Product literature

8
IMPLANTING THE S-ICD SYSTEM
This section presents the information necessary for implanting the
subcutaneous electrode using the subcutaneous electrode insertion tool (the
“EIT”). The subcutaneous electrode can also be implanted using the Cameron
Health Model 4010 Q-GUIDE EIT.
WARNING: All Boston Scientific S-ICD implantable components are
designed for use with the Boston Scientific 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 defibrillation therapy.
WARNING: Implant of the system cannot be performed in an MRI site Zone
III (and higher) as defined by the American College of Radiology Guidance
Document for Safe MR Practices3. Some of the accessories packaged with
pulse generators and electrodes, including the torque wrench and electrode
insertion tool, are not MR Conditional and should not be brought into the MRI
scanner room, the control room, or the MRI site Zone III or IV areas.
NOTE: Use of a Boston Scientific/Cameron Health electrode is required for
an implanted system to be considered MR Conditional. Refer to the MRI
Technical Guide for model numbers of system components needed to satisfy
the Conditions of Use.
The S-ICD System is designed to be positioned using anatomical landmarks.
However, it is recommended to review a pre-implant chest x-ray in order to
confirm that a patient does not have notably atypical anatomy (e.g.,
dextrocardia). Additionally, it is not recommended to deviate from the implant
instructions to accommodate for physical body size or habitus, unless a pre-
implant chest x-ray has been reviewed.
The device and subcutaneous electrode are typically implanted
subcutaneously in the left thoracic region (Figure 1 Placement of the S-ICD
System on page 9). The EIT is used to create the subcutaneous tunnels in
which the electrode is inserted.
3. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007

9
Figure 1. Placement of the S-ICD System
Creating the Device Pocket
The device is implanted in the left lateral thoracic region. To create the device
pocket, make an incision such that the device can be placed in the vicinity of
the left 5th and 6th intercostal spaces and near the mid-axillary line (Figure 2
Creating the Device Pocket on page 9) and secured to the fascial plane
covering the serratus muscle. This can be accomplished by making an incision
along the inframammary crease.
Figure 2. Creating the Device Pocket
Implanting the EMBLEM S-ICD Subcutaneous
Electrode
The procedure described below is one of several surgical approaches that can
be used to appropriately implant and position the electrode. Regardless of the
surgical approach, the defibrillation coil must be positioned parallel to the
sternum, in close proximity to, or in contact with the deep fascia, approximately
2 cm from the sternal midline (Figure 1 Placement of the S-ICD System on
page 9). In addition, good tissue contact with the electrode and pulse generator
is important to optimize sensing and therapy delivery. Use standard surgical

10
techniques to obtain good tissue contact. For example, keep the tissue moist
and flushed with sterile saline, express any residual air out through the
incisions prior to closing and, when closing the skin, take care not to introduce
air into the subcutaneous tissue.
1. Make a small, 2 cm horizontal incision at the xiphoid process (xiphoid
incision).
NOTE: If desired, in order to facilitate attachment of the suture sleeve to the
fascia following electrode placement, two suture ties to the fascia can be made
at the xiphoid incision prior to continuing.
2. Insert the distal tip of the EIT at the xiphoid incision and tunnel laterally
until the distal tip emerges at the device pocket.
CAUTION: Use only the electrode insertion tool to create the subcutaneous
tunnel when implanting and positioning the subcutaneous electrode. Avoid
tunneling close to any other subcutaneously implanted medical devices or
components, for example an implantable insulin pump, drug pump, or
ventricular assist device.
3. Using conventional suture material, tie the anchoring hole of the
subcutaneous electrode to the EIT creating a long 15-16 cm loop (Figure 3
Connecting the Distal End of the Subcutaneous Electrode to the EIT on
page 10).
Figure 3. Connecting the Distal End of the Subcutaneous Electrode to the EIT

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4. With the subcutaneous electrode attached, carefully pull the EIT back
through the tunnel to the xiphoid incision until the proximal sensing
electrode emerges.
5. Place a suture sleeve over the subcutaneous electrode shaft 1 cm below
the proximal sensing electrode. Using the preformed grooves, bind the
suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar
non-absorbable suture material, making sure not to cover the proximal
sensing electrode. Check the suture sleeve after anchoring to assure
stability by grasping the suture sleeve with fingers and trying to move the
subcutaneous electrode in either direction.
NOTE: Do not secure the suture sleeve and subcutaneous electrode to
the fascia until electrode placement is complete.
6. Make a second incision approximately 14 cm superior to the xiphoid
incision (superior incision). If desired, place the exposed subcutaneous
electrode on the skin to make this measurement. The distance between
the superior and xiphoid incisions must accommodate the portion of the
subcutaneous electrode from the distal sensing electrode to the proximal
sensing electrode. Pre-place one or two fascial sutures in superior
incision. Use a non-absorbable suture material of appropriate size for long
term retention. Apply gentle traction to ensure adequate tissue fixation.
Retain the needle on the suture for later use in passing through the
electrode anchoring hole.
7. Insert the distal tip of the EIT into the xiphoid incision and tunnel
subcutaneously towards the superior incision, staying as close to the deep
fascia as possible (Figure 4 Tunneling to Superior Incision on page 11).
Figure 4. Tunneling to Superior Incision

12
8. Once the distal tip of the EIT emerges from the superior incision,
disconnect and retain the suture loop from the distal tip of the EIT. Secure
the ends of the suture with a surgical clamp. Remove the EIT.
9. Using the secured suture at the superior incision, carefully pull the suture
and subcutaneous electrode through the tunnel until the anchoring hole
emerges. The subcutaneous electrode should be parallel to the sternal
midline with the defibrillation coil in close proximity to the deep fascia.
10. Cut and discard the suture material.
11. At the xiphoid incision, secure the suture sleeve with the subcutaneous
electrode to the fascia using 2-0 silk or similar non-absorbable suture
material.
WARNING: 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.
CAUTION: Do not suture directly over the subcutaneous electrode body, as
this may cause structural damage. Use the suture sleeve to prevent
subcutaneous electrode movement.
CAUTION: Suture only those areas indicated in the implant instructions.
NOTE: Ensure that the suture is securely fastened to fascia by gently tugging
on the suture prior to tying to the suture sleeve and subcutaneous electrode.
12. At the superior incision, secure the anchoring hole to the fascia using the
pre-placed sutures from step 6 (Figure 5 Anchoring the Distal Tip of the
Subcutaneous Electrode on page 12).
Figure 5. Anchoring the Distal Tip of the Subcutaneous Electrode
NOTE: Ensure that the suture is securely fastened to fascia by gently tugging
on the suture prior to tying to the subcutaneous electrode anchoring hole.

13
13. Gently tug the subcutaneous electrode at the superior incision to ensure
the anchoring hole is secured to the fascia.
14. To dispose of the EIT, return the used product to the original package, then
dispose in a biohazard container.
15. To ensure good tissue contact with the implanted subcutaneous electrode,
flush the xiphoid and superior incisions with sterile saline solution and
apply firm pressure along the electrode to express any residual air out
through the incisions prior to closing.
For information on connecting the subcutaneous electrode to the pulse
generator, as well as information about setup of the pulse generator and
defibrillation testing, refer to the appropriate S-ICD pulse generator user’s
manual. (Either the Boston Scientific EMBLEM S-ICD Pulse Generator User’s
Manual or the Cameron Health SQ-RX Model 1010 Pulse Generator User’s
Manual, depending on which S-ICD pulse generator is being used.) Additional
information on post implant follow-up and explant of the system can also be
found in the S-ICD pulse generator manual.
POST-IMPLANT
Post Implant Follow-Up Procedures
It is recommended that device functions be evaluated with periodic follow-up
testing by trained personnel to enable review of device performance and
associated patient health status throughout the life of the device. Refer to the
appropriate pulse generator literature for more information.
WARNING: Always have external defibrillation 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.
During a follow-up procedure, it is recommended that the location of the
subcutaneous electrode be periodically verified by palpation and/or X-ray.
When device communication with the programmer is established, the
programmer automatically notifies the physician of any unusual conditions.
Refer to the EMBLEM S-ICD Programmer User’s Manual for more information.
Patient management and follow-up are at the discretion of the patient’s
physician, but are recommended one month after implant and at least every 3
months to monitor the condition of the patient and evaluate device function.
Explantation
NOTE: Return all explanted pulse generators and subcutaneous electrodes
to Boston Scientific. Examination of explanted pulse generators and
subcutaneous electrodes can provide information for continued improvement in
system reliability and warranty considerations.
WARNING: 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

14
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.
Contact Boston Scientific when any of the following occur:
• When a product is removed from service.
• In the event of patient death (regardless of cause), along with an autopsy
report, if performed.
• For other observation or complication reasons.
NOTE: Disposal of explanted pulse generators and/or subcutaneous
electrodes is subject to applicable laws and regulations. For a Returned
Product Kit, contact Boston Scientific using the information on the back cover.
CAUTION: Clean and disinfect implanted components using standard
biohazard handling techniques.
Consider the following items when explanting and returning the pulse generator
and/or subcutaneous electrode:
• Interrogate the pulse generator and print all reports.
• Deactivate the pulse generator before explantation.
• Disconnect the subcutaneous electrode from the pulse generator.
• If subcutaneous electrode is explanted, attempt to remove it intact, and
return it regardless of condition. Do not remove the subcutaneous
electrode with hemostats or any other clamping tool that may damage it.
Resort to tools only if manual manipulation cannot free the subcutaneous
electrode.
• Wash, but do not submerge, the pulse generator and subcutaneous
electrode to remove body fluids and debris using a disinfectant solution.
Do not allow fluids to enter the pulse generator's connector port.
• Use a Boston Scientific Returned Product Kit to properly package the
pulse generator and/or subcutaneous electrode, and send it to Boston
Scientific.