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.

2
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.

3
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