Boston Scientific RELIANCE 4-FRONT DF4-LLHH User manual

PHYSICIAN’S LEAD MANUAL
RELIANCE 4–FRONT™
Pace/Sense and Defibrillation Lead
Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors
Extendable/Retractable Fixation
REF 0657, 0658, 0675, 0676, 0692, 0693, 0695, 0696
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Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Table of Contents
INFORMATION FOR USE ............................................................................ 1
Device Description ...................................................................................... 1
Related Information..................................................................................... 2
Indications and Usage................................................................................. 3
Contraindications ........................................................................................ 3
Warnings ..................................................................................................... 3
Precautions ................................................................................................. 5
Potential Adverse Events .......................................................................... 10
PRE- IMPLANT INFORMATION................................................................. 11
Surgical Preparation.................................................................................. 12
Items Included........................................................................................... 12
Accessories............................................................................................... 12
Vein Pick ................................................................................................. 12
Radiopaque Suture Sleeve..................................................................... 12
Stylets..................................................................................................... 12
Lead Cap ................................................................................................ 13
EZ-4 Connector Tool............................................................................... 13
IMPLANTATION.......................................................................................... 14
Attaching the Connector Tool to the Lead................................................. 14
Inserting the Stylet .................................................................................... 14
Handling the Fixation Helix ....................................................................... 15
Inserting the Lead ..................................................................................... 16
Positioning Lead in Right Ventricle............................................................ 19
Lead Fixation............................................................................................. 20
Checking for Lead Stability ....................................................................... 21
Repositioning the Lead ............................................................................. 22
Evaluating Lead Performance................................................................... 22
Connection to a Pulse Generator.............................................................. 24
Electrical Performance .............................................................................. 25
Conversion Testing.................................................................................... 26
Securing the Lead ..................................................................................... 27
Tunneling the Lead ................................................................................... 28
POSTIMPLANT........................................................................................... 30
Postimplant Evaluation.............................................................................. 30
Explantation .............................................................................................. 30
SPECIFICATIONS....................................................................................... 31
Specifications (Nominal) ........................................................................... 31
Lead Introducer......................................................................................... 33
Symbols on Packaging.............................................................................. 33
Outdated version. Do not use.
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Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
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DF4-LLHH
Dual coil models, DF4–LLHH connector, extendable/retractable fixation
5
12
4
3
DF4-LLHO
Single coil models, DF4–LLHO connector, extendable/retractable fixation
1
2
4
5
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
The following are trademarks of Boston Scientificoritsaffiliates: RELIANCE 4–FRONT,
EZ-4, IROX.
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

INFORMATION FOR USE
Device Description
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.
• 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.
•GORE
TM expanded polytetrafluoroethylene (ePTFE)-covered coils2—the
ePTFE covering prevents tissue ingrowth around and between the coil
filars.
• IROX-coated tip electrode—the tip electrode is coated with IROX (iridium
oxide) to increase the microscopic surface area.
1. DF4 refers to the international standard ISO 27186:2010.
2. GORE is a trademark of W.L. Gore and Associates.
1
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

• 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
arelistedinthespecifications(Table6onpage31).
• 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.
• Extendable/Retractable fixation—the extendable/retractable helix design
anchors the distal tip electrode to the endocardial surface without support
of trabecular structures, offering various lead placement possibilities for
thetipelectrodeintherig
ht ventricle. The helix serves as the cathode
for endocardial pacing and sensing. The helix is extended and retracted
using an accessory tool.
• Fluoroscopic markers—radiopaque markers near the distal tip can be
seen under fluoroscopy. These markers show when the helix is fully
retracted or fully extended.
• 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 12).
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.
2
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Indications and Usage
This Boston Scientific lead is indicatedforuseasfollows:
• 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
protection 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.
3
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

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. For DF4-LLHH or
DF4-LLHO leads, 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, such as a
high voltage short within the header.
• Handling the terminal while tunneling. Do not contact any other portion
of the DF4-LLHH or DF4-LLHO lead terminal, other than the terminal pin,
even when the lead cap is in place.
Implant Related
• Electrode placement above midseptum. The safety and efficacy of the
tip electrode placement in the right ventricle above midseptum has not
been clinically established.
• 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.
•Usefluoroscopy to verify lead position. Use fluoroscopy to verify that
the lead tip is directed toward the apex when implanted. Other positions
may result in lead movement which could affect defibrillation efficacy.
• 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
tachyarrythmia(s) might otherwise be convertible by a pulse generator
system.
4
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
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• 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 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. Do not expose a patient
to MRI scanning. Strong magneticfields may damage the pulse generator
and/or lead system, possibly resulting in injury to or death of the patient.
•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™3for 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
USEBYdateonthepack
age 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. Donotwipeorimmersethetipelectrodein
fluid. Such treatment will reduce the amount of steroid available when
the lead is implanted.
3. Physicians’ Desk Reference is a trademark of Thomson Healthcare Inc.
5
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

• Chronic repositioning. Optimum threshold performance might not be
achieved if the lead is chronically repositioned because the steroid can
be depleted.
• Protect from surface contamination. The lead uses silicone rubber
which can attract particulate matter, and therefore, must always be
protected from surface contamination.
• Do not alter or use deformed helix. To promote proper function do not
use a lead with a deformed helix or damaged helix fixation mechanism. To
avoid electrode damage, do not attempt to straighten or realign the helix.
Avoid holding or handling the distal tip.
• Lubricants. Do not apply oil-based lubricants to the ePTFE-covered
shocking coils or it may affect electrical performance.
• Nomineraloilonleadtip. Mineral oil should never come in contact
with the helix. Mineral oil on the helix may inhibit tissue ingrowth and
conduction.
• Ensure suture sleeve position.Ensure the suture sleeve remains
proximal to the venous entry site and near the terminal boot molding
throughout the procedure until it is time to secure the lead.
Implantation
• Evaluate patient for surgery. There may be additional factors regarding
the patient’s overall health and medical condition that, while not related to
device function or purpose, could render the patient a poor candidate for
implantation of this system. Cardiac health advocacy groups may have
published guidelines that may be helpful in conducting this evaluation.
• Lead compatibility. Prior to implantation, confirm the lead-to-pulse
generator compatibility. Using incompatible leads and pulse generators
can damage the connector and/or result in potential adverse
consequences, such as undersensing of cardiac activity or failure to
deliver necessary therapy.
• Line-powered equipment. Exercise extreme caution if testing leads
using line-powered equipment because leakage current exceeding 10 µA
can induce ventricular fibrillation. Ensure that any line-powered equipment
is within specifications.
• Do not bend the lead near the lead-header interface. Insert the
lead terminal straight into the lead port. Do not bend the lead near
the lead-header interface. Improper insertion can cause insulation or
connector damage.
•Veinpick.The vein pick is not intended either for puncturing the vein
or for dissecting tissue during a cutdown procedure. Be sure that the
vein pick does not puncture the insulation of the lead. This could prevent
proper lead function.
• Do not bend lead with stylet in place. Donotbendtheleadwithastylet
in place. Bending the lead could damage the conductor and insulation
material.
6
Outdated version. Do not use.
Version überholt. Nicht verwenden.
Version obsolète. Ne pas utiliser.
Versión obsoleta. No utilizar.
Versione obsoleta. Non utilizzare.
Verouderde versie. Niet gebruiken.
Föråldrad version. Använd ej.
Παλιά έκδοση. Μην την χρησιμοποιείτε.
Versão obsoleta. Não utilize.
Forældet version. Må ikke anvendes.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.