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

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• 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 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
PRE-IMPLANT INFORMATION
Surgical Preparation
Consider the following prior to the implantation procedure:

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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). Consider marking the intended position of the implanted system components and/or incisions
prior to the procedure, utilizing anatomical landmarks or fluoroscopy as a guide. Additionally, if deviations from
the implant instructions are required to accommodate for physical body size or habitus, it is recommended that
a pre-implant chest x-ray has been reviewed.
WARNING: 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.
Items Included in Package
Store in a clean, dry area. The following pre-sterilized items are included in the EDS packaging:
• Lateral Tunneling Tool
• Lateral Sheath (pre-loaded)
• Superior Tunneling Tool
• Superior Sheath (pre-loaded)
Additionally, product literature is included.

9
IMPLANTATION
Overview
This section presents the information necessary for implanting the EMBLEM S-ICD Subcutaneous Electrode
(Model 3401 or 3501) using the EMBLEM S-ICD Electrode Delivery System (the “EDS”).
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 has not been tested and could 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 Practices2. 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.
NOTE: If the electrode terminal will not be connected to a pulse generator at the time of electrode
implantation, you must cap the electrode terminal before closing the pocket incision. The lead cap is designed
specifically for this purpose. Place a suture around the lead cap to keep it in place.
The pulse generator and subcutaneous electrode are typically implanted subcutaneously in the left thoracic
region. The electrode implant tools are used to create the subcutaneous tunnels in which the electrode is
inserted. The defibrillation coil must be positioned parallel to the sternum, in close proximity to or in contact with
the deep fascia, below adipose tissue, approximately 1-2 cm from the sternal midline (Figure 1 Placement of the
S-ICD System (Model 3501 Electrode shown) on page 10 and Figure 2 Subcutaneous Tissue Layers on page
11).
2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007

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Figure 1. Placement of the S-ICD System (Model 3501 Electrode shown)

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[1] Skin, [2] Hypodermal layer, [3] Adipose tissue, [4] Deep fascia, [5] Sub-fascial tissue (muscle or bone), [6]
Correct location for subcutaneous tunnels and the S-ICD Subcutaneous Electrode
Figure 2. Subcutaneous Tissue Layers

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Placement of the pulse generator and electrode can be achieved using various techniques. To ensure optimal
placement of the subcutaneous electrode at the fascial plane, physician preference and patient assessment
should be considered when choosing the implant method.
Care should be taken to position both the electrode and device directly on the fascia without underlying adipose
tissue. High shocking electrode impedance may be associated with adipose tissue under the coil of the
electrode, which may require repositioning of the electrode so that it is on the fascia.
In order to maximize the heart mass between the pulse generator and electrode, while maintaining acceptable
sensing parameters, transthoracic defibrillation is achieved through the positioning of an anterior electrode and
a device in the mid-axillary line or posterior axillary line.
In case of failure to convert VT/VF without adequate safety margin, either during defibrillation testing or later
spontaneous ambulatory episode(s), the physician should review the position of both the electrode and device
by use of anatomical landmarks or X-ray/fluoroscopy. A more posterior device location may reduce the
defibrillation threshold.
Depending on patient body habitus and anatomy, the physician may choose to position the device between the
serratus anterior muscle and the latissimus dorsi muscle. Device fixation to the musculature is needed to secure
its position, ensure performance, and to minimize wound complications.
Good tissue contact with the electrode and pulse generator is important to optimize sensing and therapy
delivery. Use standard surgical techniques to obtain good tissue contact. For example, keep the tissue moist
and flushed with sterile saline, expel 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.
A pocket for the pulse generator must be created prior to implanting the subcutaneous electrode. The pocket
incision is utilized during the electrode implant. Refer to the applicable S-ICD pulse generator user’s manual for
information on creating the device pocket.

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Implant the EMBLEM S-ICD Subcutaneous Electrode
The following detailed instructions describe two techniques for implanting the electrode: the two-incision
technique and the three-incision technique. Alternate surgical approaches could be considered if system
placement requirements can be achieved. The physician determines which tools and surgical technique are
used to implant and position the electrode based on the patient’s anatomical features. It is recommended that
physicians be experienced in the three-incision technique before performing the two-incision technique.
In addition to the incision(s) described below, the pocket incision is utilized when implanting the electrode.
[1] Handle, [2] Picture marking for Superior Tunneling Tool, [3] Picture marking for Lateral Tunneling Tool, [4]
Locking Collar, [5] Hub, [6] Pre-loaded Sheath, [7] Distal Tip, [8] Suture hole
Figure 3. Implant tools

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METHOD 1: TWO-INCISION TECHNIQUE (ANCHORING ELECTRODE AT XIPHOID INCISION ONLY)
This method of implanting the S-ICD subcutaneous electrode includes the pocket incision and an incision for
the electrode at the xiphoid process. It utilizes two tunneling tools of different lengths, both with pre-loaded
sheaths that are used to facilitate pushing the electrode through the subcutaneous tunnels. The electrode is
anchored to the fascia at one location only, the xiphoid incision.

15
[1] Pocket incision, [2] Xiphoid incision, [3] Lateral tunnel, [4] Superior position or incision, [5] Superior tunnel
Figure 4. Electrode Implant Schematic

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Lateral Tunnel
1. Make a small, 2 cm horizontal incision at the xiphoid process (xiphoid incision). The size and orientation
may vary at the physician’s discretion based on the patient’s body habitus.
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 placed at the xiphoid incision prior to continuing.
NOTE: Ensure that the sutures are securely fastened to fascia by gently tugging on the sutures.
2. Using the lateral (longer) tunneling tool, verify that the locking collar is securely fastened to the pre-loaded
sheath.
NOTE: Over-rotation of the locking collar will release the sheath from the tunneling handle.
3. Insert the distal tip of the tunneling tool, with pre-loaded sheath, at the xiphoid incision and tunnel laterally
until the distal tip emerges at the pocket incision (Figure 5 Lateral Tunnel on page 17).