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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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.
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Utdatert versjon. Skal ikke brukes.
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Elavult verzió. Ne használja!
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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
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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.
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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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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
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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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Elavult verzió. Ne használja!
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• 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!
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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
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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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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
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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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Utdatert versjon. Skal ikke brukes.
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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
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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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Utdatert versjon. Skal ikke brukes.
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• 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
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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.

• Tools applied to distal end. Do not apply tools to the distal end of the
lead because lead damage could occur. Avoid holding or handling the
distal tip of the lead.
• Curving the stylet. Do not use a sharp object to curve the distal end of
a stylet. Do not curve a stylet while it is in the lead. If a curved stylet is
preferred, gently curve a straight stylet before inserting it into the lead to
avoid damage to the stylet and lead.
• Connector Tool handling technique. Thehelixcanbecome
unintentionally extended if the Connector Tool fixation knob is engaged
on the terminal pin and the lead body is rotated counterclockwise while
the fixation knob is held stationary.
• Do not overextend or over-retract the helix. Do not overextend or
over-retract the helix. The lead can be damaged if you continue to rotate
the terminal pin once the helix is fully extended or retracted.
• Terminal pin maximum number of turns. Do not rotate the terminal pin
clockwise or counterclockwise more than the number of turns indicated
in the specifications (Table 6 on page 31). Continuing to rotate the
terminal pin once the helix is fully extended or retracted (as indicated by
fluoroscopy) can damage the lead, cause lead dislodgment, tissue trauma,
and/or cause acute pacing thresholdtorise.
• Ensure helix is retracted. Do not insert a lead into the vein when the
helix is extended, as this may cause damage to the tissue and/or lead.
Prior to insertion in the vein, rotate the terminal pin counterclockwise to
retract the helix into the distal lead tip.
• Helix retraction during implant. Do not continue to use the lead if the
helix cannot be retracted during implant. Continuous counterclockwise
rotation of the lead body during lead removal is necessary to avoid
inadvertent tissue trauma and accidental fixation, and to release the
electrode helix if tissue snagging has occurred.
• Do not implant lead under clavicle. When attempting to implant the
lead via a subclavian puncture, do not insert the lead under the medial
one-third region of the clavicle. Damage or chronic dislodgment to the
lead is possible if the lead is implanted in this manner. If implantation
via the subclavian vein is desired, the lead must enter the subclavian
vein near the lateral border of the first rib and must avoid penetrating the
subclavius muscle. It is important to observe these implant precautions
to avoid clavicle/first rib damage or chronic dislodgment to the lead. It
has been established in the literature that lead fracture can be caused by
lead entrapment in such soft tissue structures as the subclavius muscle,
costocoracoid ligament, or the costoclavicular ligament.4
4. Magney JE, et al. Anatomical mechanisms explaining damage to pacemaker leads, defibrillator
leads, and failure of central venous catheters adjacent to the sternoclavicular joint. PACE.
1993;16:445–457.
7
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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.

• Electrode distance from pacemaker. For patients with bipolar cardiac
pacemakers, the lead pace/sense electrode (the tip electrode and distal
coil electrode) should be placed as far as possible from the pacemaker
electrodes to avoid cross-sensing between the defibrillator pulse generator
and the pacemaker.
• Thin RV free wall. If the patient has a thin RV free wall, another fixation
site should be considered.
• Lead dislodgment. Should dislodgment occur, immediate medical care
is required to resolve the electrode position and minimize endocardial
trauma.
• Prevent dislodgment. To prevent dislodgment, avoid rotating the terminal
pin after fixating the lead.
• Unauthorized delivery tools. Do not use unauthorized delivery tools to
deliver the lead because it may cause lead damage or patient injury.
• Inaccurate rate counting. R-wave amplitudes of less than the
recommended value can cause inaccurate rate counting in the chronic
state, possibly resulting in failure to sense a tachyarrhythmia or
misdiagnosis of a normal rhythm as abnormal. Signal durations that
exceed the programmed refractory period of the pulse generator can
cause inaccurate rate sensing which may cause inappropriate behavior.
• Avoid tight stricture. When ligating the vein, avoid stricture that is too
tight. A tight stricture might damage the insulation or sever the vein. Avoid
dislodging the electrode tip during the anchoring procedure.
• Avoid removal of suture sleeve. Avoid removing or cutting the suture
sleeve from the lead as it can cause lead damage.
• Do not suture directly over lead. Do not suture directly over the lead
body, as this may cause structural damage. Use the suture sleeve
to secure the lead proximal to the venous entry site to prevent lead
movement.
• Tunnel the lead. Tunnel the lead from the chest area to the pulse
generator implant site. Never tunnel the lead from the pulse generator
implant site to the chest area because this can damage the electrodes or
lead body or both by permanently stretching the lead.
• Excessive tension on lead. When tunneling the lead, take precautions
not to place excessive tension on the lead. This can cause either structural
weakness and/or conductor discontinuity.
• Re-evaluate the lead after tunneling. After tunneling, re-evaluate the
lead to verify that no significant change in signals or damage to the lead
has occurred during the tunneling procedure. Reattach the Connector Tool
and repeat the steps in Evaluating Lead Performance.
8
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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.
Zastaralá verze. Nepoužívat.
Utdatert versjon. Skal ikke brukes.
Zastaraná verzia. Nepoužívať.
Elavult verzió. Ne használja!
Wersja nieaktualna. Nie używać.

Hospital and Medical Environments
• Electrocautery. Electrocautery may induce ventricular arrhythmias
and/or fibrillation, and may cause asynchronous pacing, inhibited pacing,
inappropriate shocks, and/or a reduction in pulse generator pacing output
possibly leading to loss of capture.
If electrocautery is medically necessary, observe the following to
minimize risk to the lead. Also, refer to pulse generator labeling for
device programming recommendations and additional information about
minimizing risk to the patient and system.
• Avoid direct contact between the electrocautery equipment and the
pulse generator or leads.
• Keep the path of the electrical current as far away as possible from
the pulse generator and leads.
• If electrocautery is performed on tissue near the device or leads,
monitor pre- and post- measurements for sensing and pacing
thresholds and impedances to determine the integrity and stability
of the system.
• Use short, intermittent, and irregular bursts at the lowest feasible
energy levels.
• Use a bipolar electrocautery system where possible.
• Radio frequency (RF) ablation. RF ablation may induce ventricular
arrhythmias and/or fibrillation, and may cause asynchronous pacing,
inhibition of pacing, inappropriate shocks, and/or a reduction in pulse
generator pacing output possibly leading to loss of capture. RF ablation
may also cause ventricular pacinguptotheMaximumTrackingRate
(MTR) and/or changes in pacing thresholds. Additionally, exercise caution
when performing any other type of cardiac ablation procedure in patients
with implanted devices.
If RF ablation is medically necessary, observe the following to minimize risk
to the lead. Also, refer to pulse generator labeling for device programming
recommendations and additional information about minimizing risk to the
patient and system.
• Avoid direct contact between the ablation catheter and the pulse
generator and leads. RF ablation close to the lead electrode may
damage the lead-tissue interface.
• Keep the path of the electrical current as far away as possible from
the pulse generator and leads.
• If RF ablation is performed on tissue near the device or leads, monitor
pre- and post-measurements for sensing and pacing thresholds and
impedances to determine the integrity and stability of the system.
• Central line guidewire insertion. Use caution when inserting guidewires
for placement of other types of central venous catheter systems such as
PIC lines or Hickman catheters in locations where pulse generator leads
may be encountered. Insertion of such guidewires into veins containing
leads could result in the leads being damaged or dislodged.
9
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.

Follow-up Testing
• Unsuccessful conversion testing. Following an unsuccessful
high-energy shock, miscounting of cardiac rate, delayed detection, or
nondetection due to low amplitude VF signals, it may be necessary to
reposition the lead.
• Lead performance in chronic state. For some patients, lead
performance at implant may not predict performance in the chronic state.
Therefore, it is strongly recommended that post-implant follow-up EP
testing be performed should any change occur in lead performance. This
testing should include at least one arrhythmia induction/conversion test of
ventricular fibrillation.
Potential Adverse Events
Based on the literature and on pulse generator implant experience, the
following list includes the possible adverse events associated with implantation
of a pulse generator and/or lead system:
• Air embolism
• Allergic reaction
• Arterial damage with subsequent stenosis
• Bleeding
• Breakage/failure of the implant instruments
• Cardiac tamponade
• Chronic nerve damage
• Component failure
• Conductor coil fracture
•Death
• Elevated thresholds
•Erosion
• Excessive fibrotic tissue growth
• Extracardiac stimulation (muscle/nerve stimulation)
• Formation of hematomas or seromas
• Hemorrhage
• Hemothorax
• Inability to defibrillate or pace
• Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP]
where applicable, pacing)
• Incomplete lead connection with pulse generator
• Infection
• Lead dislodgment
• Lead fracture
10
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.

• Lead insulation breakage or abrasion
• Lead tip deformation and/or breakage
• Malignancy or skin burn due to fluoroscopic radiation
• Myocardial trauma (e.g., cardiac perforation, irritability, injury)
• Myopotential sensing
• Oversensing/undersensing
• Pericardial rub, effusion
• Pneumothorax
• Pulse generator and/or lead migration
• Shunting current during defibrillation with internal or external paddles
• Tachyarrhythmias, which include acceleration of arrhythmias and early,
recurrent atrial fibrillation
• Thrombosis/thromboemboli
• Valve damage
• Venous occlusion
• Venous trauma (e.g., perforation, dissection, erosion)
PRE- IMPLANT INFORMATION
Proper surgical procedures and techniques are the responsibility of the
medical professional. The described implant procedures are furnished only for
informational purposes. Each physician must apply the information in these
instructions according to professional medical training and experience.
The lead is designed, sold, and intended for use only as indicated.
A major consideration choosing this lead family is that it does not require a
thoracotomy. The physician should weigh its advantages against the patient’s
ability to withstand additional electrophysiology (EP) testing (arrhythmia
induction and conversion test), and a possible thoracotomy, should the lead
system prove ineffective.
Various factors, such as disease state or drug therapy, may necessitate
repositioning of the defibrillation leads or substitution of one lead system for
another in order to facilitate arrhythmia conversion. In some cases, reliable
arrhythmia conversion may not be obtained with any leads at the available
defibrillation or pulse generator defibrillation energy levels.
Bipolar pacemakers may be used with this lead family and pulse generator as
long as the pacemaker and pulse generator do not interact, causing pulse
generator nondetection or false detection. Refer to the pulse generator
physician’s manual for information about minimizing pacemaker interaction.
11
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.

Surgical Preparation
Consider the following prior to the implantation procedure:
• Instrumentation for cardiac monitoring, imaging (fluoroscopy), external
defibrillation, and lead signal measurements must be available during
implant.
• Always isolate the patient from potentially hazardous leakage current
when using electrical instrumentation.
• Sterile duplicates of all implantable items should be available for use if
accidental damage or contamination occurs.
Items Included
The following items are packaged with the lead:
Vein pick
Stylets
Connector Tool
Literature
Accessories
Separately packaged lead accessories are available in addition to those
packaged with the lead.
Vein Pick
The vein pick is a disposable plastic device designed to assist with insertion
intoaveinduringacutdownproced
ure.
Radiopaque Suture Sleeve
The radiopaque suture sleeve is an adjustable, tubular reinforcement that is
visible under fluoroscopy. It is positioned over the outer lead insulation and
is designed to secure and protect the lead at the venous entry site after lead
placement. Using a suture sleeve reduces the possibility of structural damage
caused by suturing directly over the lead body. To move the suture sleeve,
gently pinch and slide it over the lead until it is in the desired position. The
window feature is designed to aid compression of the sleeve onto the lead
during suturing.
NOTE: A radiopaque suture sleeve is pre-loaded on the lead and is also
available in a slit form as an accessory (Model 6403). The accessory slit suture
sleeve is intended to be used as a replacement for the pre-loaded suture
sleeve in the event of damage or loss.
Stylets
Stylets aid in positioning the lead. Ensure you use the length appropriate to
the lead. Stylets of various degrees of stiffness are available depending on
implant technique and patient anatomy.
12
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 1. Stylet stiffness and knob color
Stylet Stiffness aKnob Color
Soft Green
Firm White
a. The stylet stiffness is imprinted on the knob.
Table 2. Stylet length and cap color
Stylet Length (cm) (Imprinted on cap
of the knob)
Cap Color
59 Yellow
64 Green
70 Black
Lead Cap
Theleadcapmaybeusedtoisolateorcaptheleadterminalthatisnotinserted
in the pulse generator. Place a suture around the lead cap groove to secure
the lead cap to the lead terminal. Use an appropriate cap for lead.
NOTE: The lead cap (Model 7007) is available as an accessory.
EZ-4 Connector Tool
The EZ-4 Connector Tool is packaged with the lead and when attached to the
lead performs the following functions:
• Protects the lead terminal during the implant procedure.
• Provides a safe and secure connection between PSA patient cables and
the lead terminal.
• Guides the stylet into the lead through the stylet funnel.
• Rotates the terminal pin clockwise or counterclockwise to extend or retract
the helix.
[1] Fixation knob (disengaged) [2] Stylet funnel [3] Rotation mark [4] Terminal boot levers
[5] Indicator arrows [6] Anode (+) spring contact [7] Cathode (-) spring contact
Figure 1. Connector Tool
13
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.

IMPLANTATION
NOTE: Select the appropriate lead length for a given patient. It is important
to select a lead that is long enough to avoid any sharp angles or kinks and to
allow for a gentle curve of excess lead in the pocket. Typically, a minimum
of 5 to 10 cm of excess lead is sufficient to achieve this configuration in the
pocket. The suture sleeve should be secured to the lead as close to the
vascular access site as clinically appropriate as described in "Securing the
Lead" on page 27. Proper placement of the suture sleeve aids in maintaining
this configuration in the pocket.
Attaching the Connector Tool to the Lead
Follow the steps below to attach the Connector Tool to the lead.
1. Slide the Connector Tool onto the proximal end of the lead (Figure 2 on
page 14).
2. Pinch the terminal boot levers and continue sliding the Connector Tool
until the terminal boot molding aligns with the indicator arrows to ensure
the lead is fully inserted.
3. Release the terminal boot levers to secure the Connector Tool to the
proximal end of the lead.
[1] Indicator arrows [2] Terminal boot molding [3] Terminal molding
Figure 2. Lead fully inserted into Connector Tool
Inserting the Stylet
Follow the steps below to insert a stylet.
1. Remove any preinserted stylet before inserting a different one.
2. Select a stylet according to the function and to the preferred firmness.
If desired, gently curve the stylet with any sterile, smooth-surfaced
instrument (e.g., 10-cc or 12-cc syringe barrel) (Figure 3 on page 15). A
14
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.

gentle curve is less likely to straighten than a sharp bend as the stylet
is used.
CAUTION: Do not use a sharp object to curve the distal end of a stylet.
Do not curve a stylet while it is in the lead. If a curved stylet is preferred,
gently curve a straight stylet before inserting it into the lead to avoid
damage to the stylet and lead.
6 cm
70º-90º
Figure 3. Curve the stylet
3. Carefully insert the stylet through the funnel of the Connector Tool and
terminal pin.
NOTE: To optimize insertion into the lead, do not allow body fluids to come in
contact with the stylet.
4. Ensure the stylet is fully inserted in the lead prior to inserting the lead
into the vein.
CAUTION: Do not bend the lead with a stylet in place. Bending the lead
could damage the conductor and insulation material.
Handling the Fixation Helix
Before implanting the lead, verify the mechanical functioning of the lead.
1. Grasp the Connector Tool and the terminal boot molding. To engage
the fixation knob on the terminal pin, push the fixation knob toward the
Connector Tool body to close the gap. Rotate the fixation knob clockwise
to extend the helix or counterclockwise to retract it. Visually observe the
helix extending and retracting (Figure 4 on page 15).
Figure 4. Connector Tool fixation knob engaged
15
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.

NOTE: The expected and maximum number of turns to extend or retract
thehelixareprovidedinthespecifications (Table 6 on page 31). Any curves
introduced into the stylet could increase the number of turns needed to extend
or retract the helix.
CAUTION: Do not overextend or over-retract the helix. The lead can be
damaged if you continue to rotate the terminal pin once the helix is fully
extended or retracted.
CAUTION: If the helix cannot be extended or retracted, do not use the lead.
CAUTION: 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.
2. Ensure the helix is retracted into the distal lead tip prior to inserting the
lead into the vein.
CAUTION: Do not insert a lead into the vein when the helix is extended, as
this may cause damage to the tissue and/or lead. Prior to insertion in the
vein, rotate the terminal pin counterclockwise to retract the helix into the distal
lead tip.
3. Disengage the fixation knob from the terminal pin prior to inserting the lead
intothevein(Figure5onpage16).
Figure 5. Connector Tool fixation knob disengaged
Inserting the Lead
The lead may be inserted using one of the following methods: via the cephalic
vein, or through the subclavian or internal jugular vein.
•Via cutdown through the left or right cephalic vein
Only one incision over the deltopectoral groove is required to access the
right or left cephalic vein in the deltopectoral groove.
The vein pick packaged with this lead can be used to aid access during
the cutdown procedure. Isolate the selected vein and introduce the point
of the vein pick via this incision into the lumen of the vein. With the point
of the vein pick facing in the direction of the desired lead passage, gently
raise and tilt the pick. Pass the lead under the vein pick and into the vein.
16
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.