Boston Scientific EMBLEM S-ICD User manual

USER’S MANUAL
EMBLEM™S-ICD
Electrode Delivery System
REF 4712

Table of Contents
Description......................................................................................................................................1
Trademark Information ....................................................................................................................1
Related Information.........................................................................................................................1
Indications for Use ..........................................................................................................................1
Contraindications ............................................................................................................................1
Warnings ........................................................................................................................................2
Precautions.....................................................................................................................................4
Potential Adverse Events ................................................................................................................5
Pre-Implant Information...................................................................................................................7
Surgical Preparation ..............................................................................................................7
Items Included in Package .....................................................................................................8
Implantation ....................................................................................................................................9
Overview................................................................................................................................9
Implant the EMBLEM S-ICD Subcutaneous Electrode ..........................................................13
Connect the Subcutaneous Electrode to the Pulse Generator...............................................31
EMBLEM S-ICD Electrode Delivery System Diagram ....................................................................31
EMBLEM S-ICD Electrode Delivery System Specifications............................................................32
Definitions of Package Label Symbols...........................................................................................33
Warranty Disclaimer......................................................................................................................35

1
DESCRIPTION
The EMBLEM S-ICD Electrode Delivery System (the "EDS") is a component of the Boston Scientific S-ICD
System, which is prescribed for patients when cardiac arrhythmia management is warranted. The EDS consists
of two tunneling tools with pre-loaded introducer sheaths and is used to create subcutaneous tunnels to
facilitate implantation of the EMBLEM S-ICD Subcutaneous Electrode. The EDS is also compatible with S-ICD
Electrode models 3401 and 3501.
TRADEMARK INFORMATION
The following are trademarks of Boston Scientific Corporation or its affiliates: EMBLEM.
RELATED INFORMATION
Instructions in this manual should be used in conjunction with other resource material, including the applicable
S-ICD pulse generator user’s manual and subcutaneous electrode 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 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 stimulation 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
applicable 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 has not been tested and could 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. Use care when
tunneling to avoid injury to the implanter.

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•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
•Arm positioning. Attention is required to placement of the arm ipsilateral to the device implant to avoid
injury of the ulnar nerve and brachial plexus while the patient is in the supine position during device
implantation and before VF induction or shock delivery. The patient should be positioned with the arm
abducted to an angle of no more than 60° with the hand in a supinated (palm up) position during the
implant phase of the procedure. Securing the arm to an arm board is standard practice to maintain
positioning of the arm during device implantation. Do not strap the arm too tightly during defibrillation
testing. Elevation of the torso through use of a wedge may also add stress to the shoulder joint and should
be avoided during defibrillation testing.
•System migration. 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.
•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
Practices1. Some of the accessories used with pulse generators and electrodes, including the torque
wrench and electrode implant tools, 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.
1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007

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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 pouch and its contents are sterilized with ethylene oxide gas. When the EDS
is received, it is sterile provided the sterile pouch is intact. If the packaging is wet, punctured, opened, or
otherwise damaged, return the EDS to Boston Scientific.
•Use by date. Use the EDS 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 use on or after January 2.
•Storage temperature. The recommended storage temperature range is -18°C to +55°C (0°F to +131°F).
Implantation
•Creating the subcutaneous tunnels. Use Boston Scientific tools and accessories designed for use in
implanting the subcutaneous electrode to create the subcutaneous tunnels 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, sternal wiring from
previous sternotomy, or ventricular assist device.
•Superior tunnel length. Ensure the superior tunnel is long enough to accommodate the portion of the
electrode from the distal tip to the suture sleeve without buckling or curving of the defibrillation coil.
Buckling or curvature of the defibrillation coil within the superior tunnel could lead to compromised sensing
and/or therapy delivery. After insertion of the electrode into the superior tunnel, X-ray or fluoroscopy may
be used to confirm that no buckling or curvature is observed.

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•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.
•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.
For precautions related to hospital or other medical environments, refer to the applicable S-ICD pulse generator
user’s manual.
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

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• 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 defibrillate or pace
• Inappropriate post-shock pacing
• Inappropriate shock delivery
• Infection
• Injury to or pain in upper extremity, including clavicle, shoulder, and arm
• Keloid formation
• Migration or dislodgement
• Muscle/nerve stimulation
• Nerve damage
• Pneumothorax