Boston Scientific ENDOTAK RELIANCE User manual

PHYSICIAN’S LEAD MANUAL
ENDOTAK RELIANCE®
Steroid-Eluting Tined Endocardial
Defibrillation Leads
0147/0148
0128
ENDOTAK RELIANCE®S
RESTRICTED DEVICE:
Federal law (USA) restricts the sale, distri-
bution, or use of this device to, by or on
the lawful order of a physician.

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2
8
5
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ENDOTAK RELIANCE S Leads Model 0128 ENDOTAK RELIANCE Leads Models 0147/0148
1. Distal steroid-eluting pace/sense electrode (cathode) 2. Proximal pace/sense coil electrode (anode), distal defi-
brillating coil electrode
3. Proximal defibrillating coil electrode–
ENDOTAK RELIANCE only
4. Suture Sleeve
5. Yoke 6. Distal defibrillating electrode terminal (cathode) 7. Pace/sense electrode terminal 8. Proximal defibrillating electrode terminal (anode)
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6
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Table of Contents
INFORMATION FOR USE.................................................. 1
Device Description........................................................ 1
Indications .................................................................... 1
Contraindications .......................................................... 1
Warnings ...................................................................... 1
AICD/Lead Compatibility .......................................... 2
MRI Exposure........................................................... 2
Diathermy Exposure................................................. 2
Implanting................................................................. 2
Electrical Performance ............................................. 3
Conversion Testing .................................................. 3
Securing and Tunneling ........................................... 3
Single Use Only........................................................ 3
Precautions................................................................... 3
General..................................................................... 3
Adverse Events ............................................................ 4
Observed Adverse Events........................................ 4
Potential Adverse Events ......................................... 5
Clinical Trial .................................................................. 6
Clinical Investigation................................................. 7
Warranty ..................................................................... 10
DEVICE FEATURES ......................................................... 11
Detailed Device Description........................................ 11
LEAD EVALUATION......................................................... 13
Implant Information..................................................... 13
Included Items ............................................................ 13
Opening Instructions................................................... 14
Sterilization ................................................................. 14
Surgical Preparation ................................................... 14
Accessory Options...................................................... 14
Suture Sleeves ....................................................... 15
Stylets..................................................................... 15
Stylet Guide............................................................ 15
Vein Pick ................................................................ 15
Lead Caps .............................................................. 16
Handling the Lead ...................................................... 16
IMPLANTATION................................................................ 17
Inserting the Stylet ...................................................... 17
Inserting the Lead....................................................... 17
Positioning the Lead ................................................... 20
Minimizing Pacemaker Interaction.............................. 21

Checking for Lead Stability......................................... 22
Evaluating Lead Position............................................ 22
Taking Baseline Measurements............................. 22
Electrical Performance ............................................... 23
Evaluating with the Pulse Generator...................... 24
Evaluating with the PRM ........................................ 24
Conversion Testing .................................................... 24
Securing the Lead ...................................................... 26
Percutaneous Implant Technique ......................... 26
Venous Cut-Down Technique ................................ 26
Tunneling the Lead to the Abdominal Pocket ........ 28
Connection to a Pulse Generator ............................... 29
POST-IMPLANT EVALUATION....................................... 30
Follow-Up Testing ...................................................... 30
Explantation................................................................ 30
REFERENCES .................................................................. 31
SPECIFICATIONS (Nominal) .......................................... 32
SYMBOLS ON PACKAGING........................................... 33

INFORMATION FOR USE 1
INFORMATION FOR USE
Device Description
The ENDOTAK®RELIANCETM lead, Models 0147/0148, and
the ENDOTAK® RELIANCETM S lead, Model 0128, are
steroid-eluting, tined, endocardial cardioversion/defibrillation
and pace/sense leads. The ENDOTAK RELIANCE lead (dual
coil) and the ENDOTAK RELIANCE S lead (single coil) are for
use as an integral part of an AICD automatic implantable
cardioverter defibrillator system with DF-11and IS-12ports.
The lead features a small active surface area of the distal tip
electrode that is designed to increase pacing impedance.
Instructions in this manual should be used in conjunction with
other resource material including the applicable AICD device
system manual and instructions for use on any implant
accessories or tools.
This literature is intended for use by professionals trained or
experienced in device implant and/or follow-up procedures.
Indications
The ENDOTAK RELIANCE lead, Models 0147/0148, and the
ENDOTAK RELIANCE S lead, Model 0128, provide pacing
and rate-sensing and deliver cardioversion and defibrillation
shocks for AICD automatic implantable cardioverter
defibrillator systems.
Contraindications
Use of the ENDOTAK RELIANCE or ENDOTAK RELIANCE S
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 of dexamethasone acetate
• Patients with mechanical tricuspid heart valves
Warnings
In the following list of warnings, page numbers are indicated
for those warnings that are specific to other areas of the
manual. Refer to the indicated pages for information relevant
to the warning.

INFORMATION FOR USE
2
AICD/Lead Compatibility
• Do not attempt to use the ENDOTAK lead system with any
device other than a commercially available implantable
defibrillator system with which it has been tested and dem-
onstrated to be safe and effective. The potential adverse
consequences of using a combination that has not been
tested and demonstrated to be safe and effective may
include, but are not limited to, undersensing cardiac activity
and failure to deliver necessary therapy.
MRI Exposure
• Do not expose a patient to the MRI environment. Strong
electromagnetic fields in the MRI environment may
interfere with the pulse generator and lead system and
cause injury to the patient.
Diathermy Exposure
• Do not expose a patient to diathermy treatment. Shortwave
or microwave diathermy may cause injury to the patient.
Implanting
• Lead fracture, dislodgment, abrasion and/or an incomplete
connection can cause a periodic or continual loss of
rate-sensing, possibly resulting in arrhythmia nondetection;
or over-sensing of rate, possibly resulting in inappropriate
delivery of a pulse generator shock; or inadequate delivery
of conversion energy.
• Although pliable, the lead body is not designed to tolerate
excessive flexing, bending, or tension. This could cause
structural weaknesses, conductor discontinuity, and/or lead
dislodgment. (Page 16)
• 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 an
AICD system. (Page 21)
• In order to deliver defibrillation therapy, the single-coil
ENDOTAK RELIANCE S lead must be implanted with a
separate defibrillation electrode. Boston Scientific recom-
mends using the ENDOTAK RELIANCE S lead with a pec-
torally implanted device that uses the metallic housing as a
defibrillation electrode. (Page 21)

INFORMATION FOR USE 3
Electrical Performance
• When connecting the lead to the AICD pulse generator, it is
very important that proper connections are made. Damage
to the heart could result if a high-voltage defibrillating pulse
were to be delivered through the pace/sense porous tip
electrode. (Page 23)
Conversion Testing
• Use of any component of the ENDOTAK lead system to
assist in delivery of external-source rescue shocks could
cause extensive tissue damage. (Page 25)
Securing and Tunneling
• Do not kink, twist, or braid the lead terminals as doing so
could cause lead insulation abrasion damage. (Page 28)
Single Use Only
• 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.
Precautions
General
• It has not been determined whether the warnings, precau-
tions, or complications usually associated with injectable
dexamethasone acetate apply to the use of the low con-
centration, highly localized, controlled-release device. For
a listing of potentially adverse effects, refer to the Physi-
cians’ Desk Reference™.1
• Refer to the Implant Information, Implantation, and
Post-Implant Evaluation sections of this manual for cau-
tions specific to handling, implanting, and testing the
ENDOTAK RELIANCE lead family. Failure to observe
1. Physicians' Desk Reference is a trademark of Thomson Healthcare, Inc.

INFORMATION FOR USE
4
these cautions could result in incorrect lead implantation,
lead damage, and/or harm to the patient.
• This lead contains 0.87 mg dexamethasone acetate. Store
at 25° C (77° F). Excursions permitted between 15°-30°C
(59°-86° F). Transportation spikes permitted up to 50° C
(122° F).
Adverse Events
Given the similar design features, including the porous tip
electrode, steroid performance, and high pacing impedance,
the ENDOTAK ENDURANCE Rx clinical investigation was
used to support the ENDOTAK RELIANCE or ENDOTAK
RELIANCE S lead. The following are the adverse events
reported in that investigational study.
A total of two complications and six observations related to
the implanted device or system components were reported
during the clinical investigation of the ENDOTAK
ENDURANCE Rx lead. One hundred and one patients were
enrolled in the investigation, and ninety-eight were implanted
with 478.6 cumulative implant months.
Observed Adverse Events
Table 1 reports lead or system related complications and
observations for the ENDOTAK ENDURANCE Rx lead.

INFORMATION FOR USE 5
Potential Adverse Events
Based on the literature and lead implant experience, the
possible physical effects from implantation of an ENDOTAK
Table 1. ENDOTAK ENDURANCE Rx lead Study Complications
and Observations
# of
pts
(n = 98)
% of
pts
(95% Cl)
# of
leads
(n = 98)
# of
AEsa
a. AE = Adverse Event is defined as the total (lead related) complica-
tions and observations.
Complications b
(all types)
b. Complications are defined as adverse events requiring invasive mea-
sures to correct (eg, surgical intervention).
22.0%
(0.0–4.8%) 22
Hematoma 11.0%
(0.0–3.0%) 11
Noncapture (connector) 11.0%
(0.0–3.0%) 11
Observationsc
(Type I)
c. Observations are defined as adverse events which are correctable by
non-invasive measures (eg, reprogramming); Type 1 observations
are related to the implanted device or a system component.
66.0%
(1.3–10.7%) 66
Oversensing 22.0%
(0.0–4.8%) 22
Threshold difficulty 22.0%
(0.0–4.8%) 22
Telemetry 11.0%
(0.0–3.0%) 11
Inappropriate therapy 11.0%
(0.0–3.0%) 11