Boston Scientific RELIANCE 4-FRONT Series User manual

PHYSICIAN’S LEAD MANUAL
RELIANCE 4–FRONT™
Pace/Sense and Defibrillation Lead
Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors
Tined Fixation
Single Shock Coil with Silicone In-Fill
Model 0650, 0662, 0663
Dual Shock Coils with Silicone In-Fill
Model 0651, 0636, 0665
CAUTION: Federal law (USA) restricts
this device to sale by or on the order of a
physician trained or experienced in
device implant and follow-up
procedures.

Table of Contents
INFORMATION FOR USE ................................................................... 1
Device Description ...........................................................................1
Related Information ..........................................................................2
MR Conditional System Information .....................................................3
Indications and Usage.......................................................................4
Contraindications ............................................................................. 4
Warnings........................................................................................4
Precautions ....................................................................................6
Potential Adverse Events................................................................. 10
Warranty Information ...................................................................... 12
PRE- IMPLANT INFORMATION ......................................................... 12
Surgical Preparation ....................................................................... 12
Items Included............................................................................... 12
Accessories .................................................................................. 13
Vein Pick.................................................................................... 13
Radiopaque Suture Sleeve ............................................................ 13
Stylets ....................................................................................... 13
Lead Cap ................................................................................... 14
EZ-4 Connector Tool..................................................................... 14
IMPLANTATION .............................................................................. 14
Attaching the Connector Tool to the Lead ............................................ 15
Inserting the Stylet ......................................................................... 15
Inserting the Lead .......................................................................... 16
Positioning Lead in Right Ventricle ..................................................... 19
Checking for Lead Stability............................................................... 20
Evaluating Lead Performance........................................................... 20
Connection to a Pulse Generator....................................................... 22
Electrical Performance .................................................................... 23
Conversion Testing......................................................................... 23
Securing the Lead .......................................................................... 25
Tunneling the Lead......................................................................... 27
POSTIMPLANT............................................................................... 28
Postimplant Evaluation.................................................................... 28
Explantation.................................................................................. 29
SPECIFICATIONS ........................................................................... 29
Specifications (Nominal) .................................................................. 29
Lead Introducer ............................................................................. 31
Symbols on Packaging.................................................................... 31

The following are trademarks of Boston Scientific Corporation or its affiliates: EZ-4,
IMAGEREADY, IROX, RELIANCE 4–FRONT.
DUAL COIL models, DF4–LLHH connector, Tined fixation
SINGLE COIL models, DF4–LLHO connector, Tined fixation
1. Distal steroid-eluting pace/sense electrode (cathode)
2. Proximal pace/sense coil (anode), distal defibrillating coil
3. Proximal defibrillating coil (dual coil models only)
4. Suture sleeve
5. Terminal pin insertion indicator

1
INFORMATION FOR USE
Device Description
The Boston Scientific Corporation RELIANCE 4-FRONT defibrillator lead is a
7.3 French (8F introducer), transvenous, steroid-eluting, integrated bipolar, DF-
4 compatible lead intended for permanent sensing, pacing, and defibrillation
when used with a compatible Implantable Cardioverter Defibrillator (ICD) or
Cardiac Resynchronization Therapy Defibrillator (CRT-D). The RELIANCE 4-
FRONT lead family offers active and passive fixation models and single and
dual coil models, with silicone-filled defibrillator coils.
This lead family has the following characteristics:
• Endocardial cardioversion/defibrillation and pace/sense lead—intended for
chronic delivery of cardioverting/defibrillating shocks, and bipolar pacing
and sensing capabilities; implanted within the superior vena cava, right
atrium, and right ventricle.
• 4-FRONT integrated bipolar connector—intended to be connected to a
device with a DF4-LLHH port, which accepts either a DF4-LLHH or DF4-
LLHO lead. It is configured with in-line contacts and labeled as DF4-LLHH
or DF4-LLHO, described below:
– DF4: indicates the lead contains high voltage contacts1
– L: indicates a connection to a low-voltage pace/sense electrode; first L
(terminal pin)—distal pace/sense electrode; second L (proximal ring
contact)—proximal pace/sense electrode
– H: indicates a connection to a high-voltage defibrillation electrode; first
H (middle ring contact)—distal coil electrode; second H (distal ring
contact)—proximal coil electrode (dual-coil models)
– O: indicates an inactive distal ring contact (single-coil models)
NOTE: RELIANCE 4-FRONT leads with the DF4-LLHH/LLHO label are
equivalent and are compatible with a device containing either a GDT-LLHH
or DF4-LLHH port.
• MR Conditional—leads can be used as part of the ImageReady MR
Conditional Defibrillation System when connected to Boston Scientific MR
Conditional pulse generators ("MR Conditional System Information" on
page 3).
• Tip electrode—serves as the cathode for intracardiac right ventricular
pacing/sensing and uses an IROX coated electrode which may improve
pacing performance. Lower and more consistent pacing thresholds may
increase the pacing longevity of the pulse generator.
• Coil electrodes—the distal coil electrode and the proximal coil electrode
(for dual-coil models) serve as the anode and cathode during
cardioversion/defibrillation shocks. The distal coil also serves as the anode
for pacing and sensing.
1. DF4 refers to the international standard ISO 27186:2010.

2
• IROX-coated tip electrode—the tip electrode is coated with IROX (iridium
oxide) to increase the microscopic surface area.
• Steroid-eluting—upon exposure to body fluids, the steroid elutes from the
lead to help reduce tissue inflammation response at the distal electrode.
The steroid suppresses the inflammatory response believed to cause
threshold rises typically associated with implanted pacing electrodes.
Lower thresholds are desirable because they can increase pacing safety
margins and reduce pacing energy requirements, potentially increasing
pulse generator longevity. The nominal dose and structure of the steroid
are listed in the specifications (Table 5 Specifications (Nominal) on page
30).
• Radiopaque suture sleeve—the radiopaque suture sleeve is visible under
fluoroscopy and is used to secure, immobilize, and protect the lead at the
venous entry site after lead placement. The window feature is designed to
aid compression of the sleeve onto the lead during suturing.
• Tined—silicone rubber tines located proximal to the distal pacing electrode
provide fixation to the wall of the heart.
• Lead body—the isodiametric lead body contains one conductor for pacing/
sensing. Dual-coil models have two conductors for defibrillation and
single-coil models have one conductor for defibrillation. The lead
conductors are coated and insulated in separate lumens within the silicone
rubber lead body. A second layer of silicone covers the lead body to
provide additional insulation and a uniform body diameter. A layer of
polyurethane covers the proximal area of the lead body to provide
additional abrasion protection in the implantation pocket. The suture
sleeve and terminal boot molding are fabricated from molded silicone
rubber.
• Lubricious coating—the lead has a proprietary coating that makes the
surface more lubricious. This reduces both the static and dynamic
coefficients of friction, and makes the lead feel and handle like
polyurethane while providing the reliability of silicone.
• Stylet delivery method—the design consists of an open-lumen conductor
coil to enable lead delivery using a stylet. Refer to the stylet information
("Stylets" on page 13).
Related Information
Instructions in the lead manual should be used in conjunction with other
resource material, including the applicable pulse generator physician's manual
and instructions for use on any implant accessories or tools.
For additional reference information, go to www.bostonscientific-elabeling.com.
Refer to the ImageReady MR Conditional Defibrillation System MRI Technical
Guide2(MRI Technical Guide) for information about MRI scanning.
2. Available at www.bostonscientific-elabeling.com.

3
A summary of the relevant clinical study supporting this product is available as
a separate document. The following clinical summary is approved as applicable
to the leads described in this manual:
• NAVIGATE X4: RELIANCE 4–FRONT
To view and download this document, go to www.bostonscientific-elabeling.
com.
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
These leads can be used as part of the ImageReady MR Conditional
Defibrillation System when connected to Boston Scientific MR Conditional
pulse generators. Patients with an MR Conditional Defibrillation System may
be eligible to undergo MRI scans if performed when all Conditions of Use, as
defined in the MRI Technical Guide, are met. Components required for MR
Conditional status include specific models of Boston Scientific pulse
generators, leads, and accessories; the Programmer/Recorder/Monitor (PRM);
and PRM Software Application. For the model numbers of MR Conditional
pulse generators and components, as well as a complete description of the
ImageReady MR Conditional Defibrillation System, refer to the MRI Technical
Guide.
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 MR
Conditional System. For a full list of Conditions of Use, 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 the ImageReady MR Conditional Defibrillation
System3
• No other active or abandoned implanted devices, components, or
accessories present such as lead adaptors, extenders, leads, or pulse
generators
• Pulse generator implant location restricted to left or right pectoral region
• At least six (6) weeks have elapsed since implantation and/or any lead
revision or surgical modification of the MR Conditional Defibrillation
System
• No evidence of a fractured lead or compromised pulse generator-lead
system integrity
3. Defined as a Boston Scientific MR Conditional pulse generator and lead(s), with all ports
occupied by a lead or port plug.

4
Indications and Usage
This Boston Scientific lead is indicated for use as follows:
• Intended for pacing, rate-sensing, and delivery of cardioversion and
defibrillation shocks when used with a compatible pulse generator
Contraindications
Use of this Boston Scientific lead is contraindicated for the following patients:
• Patients who have a unipolar pacemaker
• Patients with a hypersensitivity to a maximum single dose of 1.1 mg
dexamethasone acetate
• Patients with mechanical tricuspid heart valves
WARNINGS
General
•Labeling knowledge. Read this manual thoroughly before implantation to
avoid damage to the pulse generator and/or lead. 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.
•Backup defibrillation protection. Always have external defibrillation
equipment available during implant and electrophysiologic testing. If not
terminated in a timely fashion, an induced ventricular tachyarrhythmia can
result in the patient's death.
•External-source rescue shocks. Do not use any component of the lead
system to assist in delivery of external-source rescue shocks or extensive
tissue damage could occur.
•Resuscitation availability. Ensure that an external defibrillator and
medical personnel skilled in CPR are present during post-implant device
testing should the patient require external rescue.
•Lead fracture. Lead fracture, dislodgment, abrasion, or an incomplete
connection can cause a periodic or continual loss of pacing or sensing or
both.
This could possibly result in arrhythmia nondetection, oversensing of rate,
inappropriate delivery of a pulse generator shock, or inadequate delivery of
converting energy.

5
Handling
•Excessive flexing. Although pliable, the lead is not designed to tolerate
excessive flexing, bending, or tension. This could cause structural
weakness, conductor discontinuity, and/or lead dislodgment.
•Do not kink leads. Do not kink, twist, or braid the lead with other leads as
doing so could cause lead insulation abrasion damage or conductor
damage.
•Handling the lead without Connector Tool. Use caution handling the
lead terminal when the Connector Tool is not present on the lead. Do not
directly contact the lead terminal with any surgical instruments or electrical
connections such as PSA (alligator) clips, ECG connections, forceps,
hemostats, and clamps. This could damage the lead terminal, possibly
compromising the sealing integrity and result in loss of therapy or
inappropriate therapy.
•Handling the terminal while tunneling. Do not contact any other portion
of the lead terminal, other than the terminal pin, even when the lead cap is
in place.
Implant Related
•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 Practices4. Some
of the accessories packaged with pulse generators and leads, including
the torque wrench and stylet wires, 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.
•Separate defibrillation electrode. In order to deliver defibrillation therapy,
the single-coil models must be implanted with an additional defibrillation
electrode. It is recommended to use the pectorally implanted defibrillator
pulse generator that uses the metallic housing as a defibrillation electrode.
•Only use Connector Tool for electrical connections. For DF4-LLHH or
DF4-LLHO leads, only use the Connector Tool for electrical connections to
pacing system analyzers or similar monitors. Do not attach alligator clips
directly to the lead terminal or damage could occur.
•Obtain appropriate electrode position. Take care to obtain appropriate
electrode position. Failure to do so may result in higher defibrillation
thresholds or may render the lead unable to defibrillate a patient whose
tachyarrhythmia(s) might otherwise be convertible by a pulse generator
system.
•Proper connections. When connecting the lead to the pulse generator, it
is very important that proper connections are made. The terminal pin must
be inserted beyond the setscrew block to enable a proper connection.
Visualization of the terminal pin insertion indicator beyond the setscrew
block may be used to confirm that the terminal pin is fully inserted into the
pulse generator port. Evaluation of the electrical performance of the lead
4. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.

6
after connection to the pulse generator is the final confirmation of full
insertion. An improper connection could result in loss of therapy or
inappropriate therapy.
Post-Implant
•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.
•Diathermy. Do not subject a patient with an implanted pulse generator
and/or lead to diathermy since diathermy may cause fibrillation, burning of
the myocardium, and irreversible damage to the pulse generator because
of induced currents.
PRECAUTIONS
Clinical Considerations
•Dexamethasone acetate. It has not been determined whether the
warnings, precautions, or complications usually associated with injectable
dexamethasone acetate apply to the use of a low concentration, highly
localized, controlled-release device. Refer to the Physicians' Desk
Reference®5for a listing of potentially adverse effects.
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 lead 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 lead to Boston Scientific.
•Storage temperature. Store at 25°C (77°F). Excursions are permitted
between 15°C to 30°C (59°F to 86°F). Transportation spikes are permitted
up to 50°C (122°F).
•Use by date. Implant the pulse generator and/or lead 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.
Handling
•Do not immerse in fluid. Do not wipe or immerse the tip electrode in fluid.
Such treatment will reduce the amount of steroid available when the lead
is implanted.
5. Physicians' Desk Reference is a registered trademark of Thomson Healthcare Inc.