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.

2

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 life­saving 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.

3

• 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
Practices

1

. 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

4

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.

5

• 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

6

• 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

7

• 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:

8

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 non­compatible 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 Practices

2

. 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

10

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

11

[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

12

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.

13

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

14

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

16

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).

17

[Top] Creating the lateral tunnel, [Middle] Passing the electrode from the pocket to the xiphoid incision through
the sheath, [Bottom] Removing the sheath, leaving the electrode in place

Figure 5. Lateral Tunnel

18

CAUTION: 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.

4. Disengage the locking collar and remove the tunneling tool from the sheath while applying forward
pressure to the hub of the sheath to stabilize it within the tunnel (Figure 5 Lateral Tunnel on page 17).

5. Starting from the distal end of the sheath at the pocket incision, push the distal tip of the electrode through
the sheath until the entire defibrillation coil has passed through the sheath and emerged at the xiphoid
incision (Figure 5 Lateral Tunnel on page 17).

6. Hold the proximal end of the electrode at the pocket to stabilize it and remove the sheath by pulling it out
through the xiphoid incision (Figure 5 Lateral Tunnel on page 17).

7. Identify the intended position of the distal tip of the electrode, at a point approximately 14 cm superior to
the xiphoid incision (superior position (Figure 4 Electrode Implant Schematic on page 15). The length of
the superior tunnel must accommodate the portion of the subcutaneous electrode from the proximal
sensing electrode to the distal tip of the electrode body. If the exposed portion of the electrode body is
placed on the skin to make this measurement, take tissue depth into account to avoid underestimating the
necessary length of the tunnel.

Anchoring the Electrode at the Xiphoid Incision

The two subcutaneous electrode models compatible with the EDS have different features for anchoring to the
deep fascia. Follow the instructions below that correspond to the model being implanted.

8. If using S-ICD Subcutaneous Electrode Model 3501, a suture sleeve is permanently affixed
(integrated) to the electrode body. Secure the integrated suture sleeve to the deep fascia with 2-0 silk or
similar non-absorbable suture material, using at least two of the four suture grooves. The integrated
suture sleeve may be anchored in a horizontal, vertical, or curved orientation (Figure 1 Placement of the
S-ICD System (Model 3501 Electrode shown) on page 10).

19

OPTIONAL: If the accessory slit suture sleeve is needed in addition to the integrated suture sleeve, attach
it to the electrode body as follows: Place the suture sleeve over the electrode shaft, making sure not to
cover the integrated suture sleeve, sensing electrodes, or defibrillation coil. Using the preformed grooves,
bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture
material. After the suture sleeve is attached to the electrode body, check that it is stable by grasping the
suture sleeve with fingers and trying to slide it along the subcutaneous electrode body in either direction.
Secure the accessory suture sleeve to the deep fascia with 2-0 silk or similar non-absorbable suture
material. The accessory suture sleeve may be anchored in a horizontal, vertical, or angled orientation.

If using S-ICD Subcutaneous Electrode Model 3401, 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. After the suture sleeve is attached to the
electrode body, check that it is stable by grasping the suture sleeve with fingers and trying to slide it along
the subcutaneous electrode body in either direction. Secure the suture sleeve to the deep fascia with 2-0
silk or similar non-absorbable suture material. The suture sleeve may be anchored in a horizontal,
vertical, or angled orientation.

WARNING: Use appropriate anchoring techniques as described in the implant procedure to prevent S­ICD 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: Anchoring the subcutaneous electrode to the fascia at the xiphoid incision may be completed
either before or after positioning the electrode in the superior tunnel per physician preference.

20

Figure 6. Anchoring Subcutaneous Electrode at Xiphoid Incision

21

Superior Tunnel

9. Using the superior (shorter) tunneling tool, verify 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.

CAUTION: 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.

10. Insert the distal tip of the tunneling tool into the xiphoid incision between the adipose and fascial plane

and tunnel subcutaneously towards the superior position, in parallel to the sternal midline, staying below
adipose tissue and as close to the deep fascia as possible (Figure 7 Superior Tunnel on page 22). Palpate
the skin to locate the distal end of the tunneling tool. It should match the desired location for the distal tip
of the electrode as identified in step 7.

22

[Left] Creating the superior tunnel, [Middle] Passing the electrode into the sheath after the tunneling tool has
been removed, [Right] Peeling the sheath to remove it from the tunnel, while stabilizing the electrode, leaving
the electrode in place. The dotted line represents the sternal midline.

Figure 7. Superior Tunnel

23

11. Disengage the sheath from the locking collar by turning the collar counter-clockwise. Remove the

tunneling tool from the sheath while applying forward pressure to the hub of the sheath to stabilize it in the
tunnel.

12. Crack the hub of the sheath.

13. Starting at the xiphoid incision, advance the distal tip of the electrode through the sheath until the distal

sensing electrode reaches the superior position. Palpate the electrode tip to confirm it is correctly
positioned (Figure 7 Superior Tunnel on page 22).

14. Stabilize the electrode at the xiphoid incision and/or at the tip to ensure that it remains in position during

sheath removal. Peel sheath to remove (Figure 7 Superior Tunnel on page 22).

15. To dispose of the implant tools, return the used product to the original package, then dispose in a

biohazard container.

16. To avoid air entrapment and ensure good tissue contact with the implanted subcutaneous electrode, flush

all incisions with sterile saline solution and apply firm pressure along the electrode to expel any residual
air out through the incisions prior to closing. Consider using fluoroscopy to check the electrode position
prior to closure.

METHOD 2: THREE-INCISION TECHNIQUE (ANCHORING ELECTRODE AT XIPHOID AND SUPERIOR
INCISIONS)

This method of implanting the S-ICD subcutaneous electrode includes the pocket incision plus two additional
incisions for the electrode at both the xiphoid process and superior position. The longer tool is used to pull the
electrode through the subcutaneous tunnels. The electrode is anchored to the deep fascia at two locations, the
xiphoid and superior incisions.

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.

24

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. The pre-loaded sheath may be used or removed according to physician preference. Use of the sheath is
described in Method 1, step 2. To remove the sheath, turn the locking collar on the tunneling tool counter­clockwise until it disengages from the sheath.

3. Insert the distal tip of the lateral (longer) tunneling tool at the xiphoid incision and tunnel laterally until the
distal tip emerges at the pocket incision.

CAUTION: 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.

4. Using conventional suture material, tie the anchoring hole at the distal end of the subcutaneous electrode
to the suture hole at the distal end of the tunneling tool, creating a long 15-16 cm loop (Figure 8
Connecting the Electrode to the Lateral Tunneling Tool on page 25).

25

Figure 8. Connecting the Electrode to the Lateral Tunneling Tool

5. With the subcutaneous electrode attached, carefully pull the tunneling tool back through the tunnel to the

xiphoid incision until the proximal sensing electrode emerges.

6. If using S-ICD Subcutaneous Electrode Model 3501, a suture sleeve is permanently affixed

(integrated) to the electrode body.

OPTIONAL: If the accessory slit suture sleeve is needed in addition to the integrated suture sleeve, attach
it to the electrode body as follows: Place the suture sleeve over the electrode shaft, making sure not to

26

cover the integrated suture sleeve, sensing electrodes, or defibrillation coil. Using the preformed grooves,
bind the suture sleeve to the subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture
material. After the suture sleeve is attached to the electrode body, check that it is stable by grasping the
suture sleeve with fingers and trying to slide it along the subcutaneous electrode body in either direction.

If using S-ICD Subcutaneous Electrode Model 3401, 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. After the suture sleeve is attached to the
electrode body, check that it is stable by grasping the suture sleeve with fingers and trying to slide it along
the subcutaneous electrode body in either direction.

NOTE: The subcutaneous electrode may be anchored to the fascia either before or after creating the
superior tunnel at the physician’s discretion. For instructions on anchoring at the xiphoid incision, see
Anchoring the Electrode at the Xiphoid Incision later in this section.

Superior Tunnel

NOTE: The length of the superior sheath is not optimized for the three-incision technique, as the distal tip of

the electrode may not protrude from the end of the sheath.

7. Identify the intended position of the superior incision, at a point approximately 14 cm superior to the
xiphoid incision (Figure 4 Electrode Implant Schematic on page 15). The length of the superior tunnel
must accommodate the portion of the subcutaneous electrode from the proximal sensing electrode to the
distal tip of the electrode body. If the exposed portion of the electrode body is placed on the skin to make
this measurement, take tissue depth into account to avoid underestimating the necessary length of the
tunnel.

8. Make the superior incision. Pre-place one or two fascial sutures in superior incision. Use a non­absorbable 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.

27

9. Insert the distal tip of the lateral (longer) tunneling tool with the electrode still attached into the xiphoid

incision between the adipose and fascial plane and tunnel subcutaneously towards the superior incision,
staying below adipose tissue and as close to the deep fascia as possible (Figure 9 Tunneling to Superior
Incision on page 28).

CAUTION: 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.

28

Figure 9. Tunneling to Superior Incision

10. Once the distal tip of the tunneling tool emerges from the superior incision, disconnect and retain the
suture loop from the distal tip of the tunneling tool. Secure the ends of the suture with a surgical clamp.
Remove the tunneling tool.

11. Using the secured suture loop 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 beneath any adipose tissue and in close proximity
to the deep fascia.

12. Cut and discard the suture material.

29

Anchoring the Electrode at the Xiphoid Incision

13. At the xiphoid incision, anchor the subcutaneous electrode to the fascia using 2-0 silk or similar non-

absorbable suture material.

If using S-ICD Subcutaneous Electrode Model 3501, use at least two of the four suture grooves when
anchoring the electrode to the fascia. The integrated suture sleeve may be anchored in a horizontal,
vertical, or curved orientation.

If using S-ICD Subcutaneous Electrode Model 3401, the suture sleeve(s) may be anchored in a
horizontal, vertical, or angled orientation.

WARNING: Use appropriate anchoring techniques as described in the implant procedure to prevent S­ICD 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.

14. At the superior incision, secure the anchoring hole at the distal end of the electrode to the fascia using the

pre-placed sutures from step 8 (Figure 10 Anchoring the Distal Tip of the Subcutaneous Electrode on
page 30).

30

Figure 10. 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.

15. Gently tug the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to
the fascia.

16. To dispose of the Electrode Delivery System, return the used products to the original package, then
dispose in a biohazard container.

17. To avoid air entrapment and ensure good tissue contact with the implanted subcutaneous electrode, flush
all incisions with sterile saline solution and apply firm pressure along the electrode to expel any residual
air out through the incisions prior to closing. Consider using fluoroscopy to check the electrode position
prior to closure.

31

Connect the Subcutaneous Electrode to the Pulse Generator

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 applicable S-ICD pulse generator user’s
manual. Additional information on post-implant follow-up and explant of the system can also be found in the
applicable S-ICD pulse generator user’s manual.

EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM DIAGRAM

[1] Handle, [2] Locking Collar, [3] Hub, [4] Distal Tip, [5] Suture hole, [6] Picture marking for Lateral Tunneling
Tool, [7] Picture marking for Superior Tunneling Tool

Figure 11. Model 4712 dimensions

32

EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM SPECIFICATIONS

Table 1. Specifications (Nominal)

Component Specifications

Tunneling Tools Materials

• Acrylonitrile-butadiene-styrene (ABS)

• Stainless steel

• Polypropylene

Sheaths (pre-loaded) Materials

• Polytetraflouroethylene (PTFE)

• Polymethylpentene (TPX™)

a

Lateral Tunneling Tool Length 39.2 cm

Lateral Sheath Length 25.7 cm

Superior Tunneling Tool Length 27.9 cm

Superior Sheath Length 14.8 cm

Lateral and Superior Tunneling Tools Tip Diameter 3.78 mm

33

Table 1. Specifications (Nominal) (continued)

Component Specifications

Sheath Size: Sheath Tip Inner Diameter 3.84 mm (11 Fr)

Transportation, Handling, and Storage Temperature
Range

-18°C to +55°C (0°F to +131°F)

a. TPX is a trademark of Mitsui Chemicals America, Inc.

DEFINITIONS OF PACKAGE LABEL SYMBOLS

The following symbols may be used on packaging and labeling.

Table 2. Packaging Symbols

Symbol Description

Sterilized using ethylene oxide

Date of manufacture

Authorized Representative in the European
Community

34

Table 2. Packaging Symbols (continued)

Symbol Description

Use by

Lot number

Reference number

Temperature limitation

Open here

Consult instructions for use on this website: www.
bostonscientific-elabeling.com

35

Table 2. Packaging Symbols (continued)

Symbol Description

Do not resterilize

Do not reuse

Do not use if package is damaged

Manufacturer

CE mark of conformity with the identification of the
notified body authorizing use of the mark

Australian Sponsor Address

WARRANTY DISCLAIMER

Except as otherwise provided herein, Boston Scientific disclaims all express and implied warranties for this
product, including without limitation any implied warranties of merchantability or fitness for a particular purpose.

36

Boston Scientific’s obligations under any warranty provided herein shall be limited strictly to replacement of the
product. Buyer assumes all risk of loss or damages arising from use of this product.

Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112-5798 USA

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1831 Diegem, Belgium

Boston Scientific (Australia) Pty Ltd
PO Box 332
Botany NSW 1455 Australia
Free Phone [phone]
Free Fax [phone]

www.bostonscientific.com

1.800.CARDIAC (227.3422)
+1.651.582.4000

©

2017 Boston Scientific Corporation or its affiliates.

All rights reserved.

360210-001 EN Europe 2017-08

Authorized 2015

*360210-001*