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
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
The following are trademarks of Boston Scientific Corporation or its affiliates: EZ-4,
IMAGEREADY, IROX, RELIANCE 4–FRONT.
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, DF4 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 4FRONT 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 DF4LLHO 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 contacts
– 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
1. DF4 refers to the international standard ISO 27186:2010.
1
• 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
2
Guide
(MRI Technical Guide) for information about MRI scanning.
2. Available at www.bostonscientific-elabeling.com.
2
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
• No other active or abandoned implanted devices, components, or
• Pulse generator implant location restricted to left or right pectoral region
• At least six (6) weeks have elapsed since implantation and/or any lead
• No evidence of a fractured lead or compromised pulse generator-lead
3
System
accessories present such as lead adaptors, extenders, leads, or pulse
generators
revision or surgical modification of the MR Conditional Defibrillation
System
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.
3
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.
4
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 Practices
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
. Some
4. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.
5
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
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.
®
5
for a listing of potentially adverse effects.
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.
6
• 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.
• No mineral oil on lead tip. Mineral oil should never come in contact with
the lead tip electrode. Mineral oil on the tip 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 leadheader interface. Improper insertion can cause insulation or connector
damage.
• Vein pick. 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. Do not bend the lead with a stylet
in place. Bending the lead could damage the conductor and insulation
material.
• 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.
7
• Do not implant lead under clavicle. When attempting to implant the lead
via a subclavian puncture, do not introduce the lead under the medial onethird 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 to avoid entrapment by the subclavius
muscle or ligamentous structures associated with the narrow
costoclavicular region. 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.
6
• 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.
• Lead dislodgment. Should dislodgment occur, immediate medical care is
required to resolve the electrode position and minimize endocardial
trauma.
• Compatible delivery tools. Only use compatible delivery tools to deliver
the lead because using incompatible delivery tools 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 distal tip during the anchoring procedure.
• 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.
• Use caution to remove suture sleeve. Avoid removing or cutting the
suture sleeve from the lead. If removal of the suture sleeve is necessary,
use caution as lead damage can occur.
• Use of multiple suture sleeves has not been evaluated. Use of multiple
suture sleeves has not been evaluated and is not recommended.
• Tunnel the lead. Tunnel the lead from the chest area to the pulse
generator implant site. Do not tunnel the lead from the pulse generator
6. 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.
8
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.
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 pacing up to the Maximum Tracking Rate
(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.
9
• 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.
Follow-up Testing
• Unsuccessful conversion testing. Following an unsuccessful highenergy 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 and/or lead implant experience,
the following alphabetical list includes the possible adverse events associated
with implantation of products described in this literature:
• Air embolism
• Allergic reaction
• Arterial damage with subsequent stenosis
• Bleeding
• Bradycardia
• Breakage/failure of the implant instruments
• Cardiac perforation
• Cardiac tamponade
• Chronic nerve damage
• Component failure
• Conductor coil fracture
• Death
• Electrolyte imbalance/dehydration
• Elevated thresholds
• Erosion
10
• Excessive fibrotic tissue growth
• Extracardiac stimulation (muscle/nerve stimulation)
• Fluid accumulation
• Foreign body rejection phenomena
• Formation of hematomas or seromas
• Heart block
• Hemorrhage
• Hemothorax
• Inability to defibrillate or pace
• Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP]
where applicable, pacing)
• Incisional pain
• Incomplete lead connection with pulse generator
• Infection including endocarditis
• Lead dislodgment
• Lead fracture
• Lead insulation breakage or abrasion
• Lead tip deformation and/or breakage
• Local tissue reaction
• Low amplitude VF signals
• Malignancy or skin burn due to fluoroscopic radiation
• Myocardial trauma (e.g., irritability, injury, tissue damage)
• Myopotential sensing
• Oversensing/undersensing
• Pericardial rub, effusion
• Pneumothorax
• Post-shock rhythm disturbances
• Pulse generator and/or lead migration
• Shunting current during defibrillation with internal or external paddles
• Syncope
• Tachyarrhythmias, which include acceleration of arrhythmias and early,
recurrent atrial fibrillation
• Thrombosis/thromboemboli
• Valve damage
• Vasovagal response
• Venous occlusion
• Venous trauma (e.g., perforation, dissection, erosion)
11
For a list of potential adverse events associated with MRI scanning, refer to the
ImageReady MR Conditional Defibrillation System MRI Technical Guide.
Warranty Information
A limited warranty certificate for the lead is available. For a copy, contact
Boston Scientific using the information on the back cover.
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.
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
12
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
into a vein during a cutdown procedure.
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.
CAUTION: Use of multiple suture sleeves has not been evaluated and is not
recommended.
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.
Table 1. Stylet stiffness and knob color
Stylet Stiffness
a
Knob 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)
59 Yellow
64 Green
70 Black
Cap Color
13
Lead Cap
The lead cap may be used to isolate or cap the lead terminal that is not inserted
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.
[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
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 25. Proper placement of the suture sleeve aids in maintaining this
configuration in the pocket.
NOTE: Refer to the MRI Technical Guide for considerations affecting choice
and implant of leads for use as part of an MR Conditional system.Use of
Boston Scientific MR Conditional pulse generators and leads is required for an
implanted system to be considered MR Conditional. Refer to the MRI Technical
Guide for model numbers of pulse generators, leads, accessories, and other
system components needed to satisfy the Conditions of Use for MR
Conditional scanning.
14
NOTE: Other implanted devices or patient conditions may cause a patient to
be ineligible for an MRI scan, independent of the status of the patient’s
ImageReady MR Conditional System.
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 Lead
fully inserted into Connector Tool on page 15).
2. While squeezing the EZ-4 Connector Tool wings, push the lead into the
tool until the white boot aligns with the arrows on the tool 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 Curve the stylet
on page 16). A 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.
15
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.
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.
CAUTION: 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.
Figure 4. Using the vein pick
• Percutaneously or via cutdown through the subclavian vein A
subclavian introducer set is available for use during percutaneous lead
insertion. Refer to the specifications for the recommended introducer size.
16
CAUTION: When attempting to implant the lead via a subclavian
puncture, do not introduce 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 to avoid entrapment by the subclavius muscle or ligamentous
structures associated with the narrow costoclavicular region. 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.
7
Leads placed by percutaneous subclavian venipuncture should enter the
subclavian vein, where it passes over the first rib (rather than more
medially), to avoid entrapment by the subclavius muscle or ligamentous
structures associated with the narrow costoclavicular region.
8
It is
recommended to introduce the lead into the subclavian vein near the
lateral border of the first rib.
The syringe should be positioned directly above and parallel to the axillary
vein to reduce the chance that the needle will contact the axillary or
subclavian arteries or the brachial plexus. Use of fluoroscopy is helpful in
locating the first rib and in guiding the needle.
The steps below explain how to identify the skin entry point and define the
course of the needle toward the subclavian vein where it crosses the first
rib.
1. Identify points St (sternal angle) and Cp (coracoid process) (Figure 5
Entry point for percutaneous subclavian venipuncture on page 18).
7. 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.
8. Magney JE, et al. A new approach to percutaneous subclavian venipuncture to avoid lead
fracture or central venous catheter occlusion. PACE. 1993;16:2133–2142.
17
[1] Subclavius muscle [2] Costocoracoid ligament [3] Costoclavicular ligament
Figure 5. Entry point for percutaneous subclavian venipuncture
2. Visually draw a line between St and Cp, and divide the segment into
thirds. The needle should pierce the skin at the junction of the middle
and lateral thirds, directly above the axillary vein (point Ax).
3. Place an index finger on the clavicle at the junction of the medial and
middle thirds (point V), beneath which point the subclavian vein
should be located.
4. Press a thumb against the index finger and project 1–2 centimeters
below the clavicle to shield the subclavius muscle from the needle
(when hypertrophy of the pectoralis muscle is apparent, the thumb
should project about 2 centimeters below the clavicle because the
subclavius muscle should be hypertrophied as well) (Figure 6
Location of thumb and needle entry on page 18).
Figure 6. Location of thumb and needle entry
18
5. Feel with the thumb the pressure from the passage of the needle
through the superficial fascia; direct the needle deep into the tissues
toward the subclavian vein and the underlying first rib. Fluoroscopic
guidance will reduce the chance that the needle would pass below the
first rib and into the lung.
Positioning Lead in Right Ventricle
Correct functioning of the lead depends on appropriate placement of the
electrodes. Follow the instructions below to position the lead.
1. Partially withdraw the stylet during lead positioning to minimize tip
stiffness.
NOTE: A curved stylet may enhance maneuverability.
2. Under fluoroscopy and with a stylet in the lead, advance the lead as far as
possible until the tip enters and becomes lodged in healthy myocardium in
the apex of the right ventricle.
WARNING: 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.
[1] Proximal coil electrode [2] Distal coil electrode
Figure 7. Suggested electrode position within the heart
19
3. Verify under fluoroscopy that the distal coil electrode is situated in the right
ventricle, below the tricuspid valve, and that the proximal coil electrode (in
dual-coil models) is situated in the superior vena cava and high right
atrium.
CAUTION: 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.
4. Ensure sufficient contact between the lead tip and the fixation site.
WARNING: 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.
Checking for Lead Stability
Follow these steps to check lead stability:
1. After fixation, partially withdraw the stylet 20 to 25 cm.
2. Check the stability of the lead using fluoroscopy. Do not tug on the lead. If
possible, have the patient cough or take several deep breaths.
3. When the electrode position is satisfactory, withdraw the stylet beyond the
right atrium.
CAUTION: Should dislodgment occur, immediate medical care is required to
resolve the electrode position and minimize endocardial trauma.
Evaluating Lead Performance
Verify electrical performance of the lead using a pacing system analyzer (PSA)
before attaching the lead to the pulse generator.
1. Connect the lead to the PSA.
• Attach the PSA cable alligator clips to the Connector Tool cathode (–)
spring contact and anode spring contact (+). Use of the Connector
Tool will protect the terminal pin from alligator clip damage and
prevent bridging between terminal contacts. Fully engage the alligator
clips on the cathode and anode spring contacts to avoid inaccurate
baseline measurements (Figure 8 PSA clips attached to Connector
Tool on page 21).
WARNING: 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.
20
Figure 8. PSA clips attached to Connector Tool
2. Perform the measurements as indicated in the table.
Table 3. Recommended threshold and sensing measurements
Signal Type Amplitude Duration Pacing
Pacing/
Sensing
≥ 5 mV < 100 ms ≤ 1.5 V 300–1200 Ω
Threshold
a
Impedance
Defibrillation ≥ 1 mV < 150 ms NA
a. Pulse width setting 0.5 ms.
20–125 Ω
• Pulse generator measurements may not exactly correlate to the PSA
measurements due to signal filtering. Baseline measurements should
fall within the recommended values indicated in the table.
• Lower intrinsic potentials, longer durations, and higher pacing
threshold may indicate lead placement in ischemic or scarred tissue.
Because signal quality may deteriorate, reposition the lead if
necessary to obtain a signal with the largest possible amplitude,
shortest duration, and lowest pacing threshold.
• Changes in the defibrillation electrode surface area, such as changing
from a TRIAD configuration to a single coil configuration, can affect
the impedance measurements. Baseline defibrillation impedance
measurements should fall within the recommended values indicated
in the table.
CAUTION: 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.
3. If measurements do not conform to the values in the table, perform the
following steps:
• Remove the PSA alligator clips from the Connector Tool.
21
• Reinsert the stylet and reposition the lead using the procedures
previously discussed and repeat the lead evaluation process.
• If testing results are unsatisfactory, further lead system repositioning
or replacement may be required.
Consider the following information:
• Low stimulation threshold readings indicate a desirable safety margin,
since stimulation threshold may rise after implantation.
• Initial electrical measurements may deviate from recommendations
because of acute cellular trauma. If this occurs, wait approximately 10
minutes and repeat testing. Values may be dependent on patientspecific factors such as tissue condition, electrolyte balance, and drug
interactions.
• Amplitude and duration measurements are not inclusive of current of
injury and are taken during the patient's normal baseline rhythm.
4. Test for diaphragmatic stimulation by pacing the lead at a high voltage
output, using professional medical judgment to select the output voltage.
Adjust the lead configurations and lead position as necessary. PSA testing
at higher outputs may also be considered to better characterize stimulation
margins. Testing should be conducted for all lead placements.
5. Once acceptable measurements are obtained, remove the pacing system
analyzer connections, and remove the stylet.
6. Pinch the terminal boot levers and slide the Connector Tool off of the
proximal end of the lead.
7. If additional repositioning and/or PSA measurements are necessary,
reattach the Connector Tool, ensuring the lead is fully inserted, and repeat
the evaluation process.
Connection to a Pulse Generator
Consult the applicable pulse generator physician's manual for more
instructions for connecting lead terminals to the pulse generator.
1. Verify the stylet and any terminal pin accessories are removed prior to
connecting the lead to the pulse generator.
2. Grasp the lead body in the labeled area distal to the terminal ring contacts
and fully insert the lead terminal into the pulse generator port until the
terminal pin is visible beyond the setscrew block. If the terminal pin is
difficult to insert, verify the setscrew is completely retracted. 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.
NOTE: If necessary, lubricate the entire lead terminal (area shown in Figure 9
DF4 Lead Terminal on page 22) sparingly with sterile water or sterile mineral oil
to make insertion easier.
Figure 9. DF4 Lead Terminal
22
3. Apply gentle traction to the lead by grasping the labeled area of the lead
body to ensure a secure connection.
CAUTION: 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.
WARNING: 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.
NOTE: If the lead terminal will not be connected to a pulse generator at the
time of lead implantation, you must cap the connector before closing the pocket
incision. The lead cap is designed specifically for this purpose. Place a suture
around the lead cap to keep it in place.
4. Giving consideration to patient anatomy and pulse generator size and
motion, gently coil any excess lead and place adjacent to the pulse
generator. It is important to place the lead into the pocket in a manner that
minimizes lead tension, twisting, sharp angles, and/or pressure.
Electrical Performance
1. Evaluate the lead signals using the pulse generator.
2. Place the pulse generator into the implant pocket as indicated in the pulse
generator physician's manual. Also refer to the instructions in this manual
("Connection to a Pulse Generator" on page 22).
3. Evaluate the lead signals by viewing the real-time EGM. Consider the
following:
• The signal from the implanted lead should be continuous and without
artifact, similar to a body-surface ECG.
• A discontinuous signal may indicate a lead fracture or an otherwise
damaged lead, or an insulation break that would necessitate lead
replacement.
• Inadequate signals may result either in a failure of the pulse generator
system to detect an arrhythmia or in an unnecessary delivery of
therapy.
4. Test for diaphragmatic stimulation by pacing the lead at a high voltage
output, using professional medical judgment to select the output voltage.
Adjust the lead configurations and lead position as necessary. Testing
should be conducted for all lead placements.
Conversion Testing
After obtaining acceptable signals, use the pulse generator to demonstrate
ability to reliably convert ventricular fibrillation (VF) and, when appropriate to
the patient, ventricular tachycardias. This testing involves inducing arrhythmias
23
and shocking the patient with high-voltage pulses delivered from the pulse
generator, through the defibrillation electrodes of the lead, to the heart.
Baseline measurements should fall within the recommended values listed in
the Recommended threshold and sensing measurements table (Table 3
Recommended threshold and sensing measurements on page 21).
CAUTION: 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.
WARNING: 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.
Reliable conversion of VF should be demonstrated at an energy level less than
the maximum energy setting of the pulse generator. Consider the following:
• It is recommended that multiple induction conversion tests of VF be
performed to determine conversion reliability and the patient’s defibrillation
threshold (DFT).
• It is a matter of clinical judgment as to what constitutes a demonstration of
reliable conversion. Since the result of any single test is subject to
statistical variation, a one-time conversion of a rhythm disturbance at a
particular energy level does not necessarily predict future conversion
energy levels.
• Refer to the applicable pulse generator physician's manual for conversion
testing guidelines.
• Weigh the probability of reliable conversion in the ambulatory state against
the availability of the pulse generator energy settings and the patient’s
ability to tolerate multiple arrhythmia inductions.
• If a patient’s arrhythmia(s) cannot be reliably converted with the lead,
supplementary implantation of an alternate lead system will require
additional conversion testing.
WARNING: Do not use any component of the lead system to assist in
delivery of external-source rescue shocks or extensive tissue damage
could occur.
• The decision to implant any pulse generator lead system in any
configuration should be based on demonstration of adequate safety
margins at the programmed shock energy as determined by DFT and
cardioversion energy requirement (CER) testing. Refer to the applicable
pulse generator physician’s manual for DFT and CER testing
requirements.
• Clinical study indicates that a programmed safety margin of 9–10 J above
the patient’s DFT was used in the majority of patients. If a 9–10 J safety
margin cannot be obtained, consider placing an alternative defibrillation
lead system.
NOTE: If, after prolonged and repeated inductions of VF, a thoracotomy
is to be performed, consider performing it at a later date.
24
Securing the Lead
After the electrodes are satisfactorily positioned, use the suture sleeve to
secure the lead to achieve permanent hemostasis and lead stabilization.
Suture sleeve tie-down techniques can vary with the lead insertion technique
used. Consider the following warning and precautions while securing the lead.
WARNING: Do not kink, twist, or braid the lead with other leads as doing so
could cause lead insulation abrasion damage or conductor damage.
CAUTION: When ligating the vein, avoid stricture that is too tight. A tight
stricture might damage the insulation or sever the vein. Avoid dislodging the
distal tip during the anchoring procedure.
CAUTION: 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.
CAUTION: Avoid removing or cutting the suture sleeve from the lead. If
removal of the suture sleeve is necessary, use caution as lead damage can
occur.
CAUTION: Use of multiple suture sleeves has not been evaluated and is not
recommended.
Percutaneous Implant Technique
1. Peel back the introducer sheath and slide the suture sleeve deep into the
tissue (Figure 10 Example of suture sleeve, percutaneous implant
technique on page 25).
Figure 10. Example of suture sleeve, percutaneous implant technique
25
2. Using at least two grooves, ligate the suture sleeve and the lead to the
fascia. For additional stability, the sleeve may be secured to the lead first
before securing the sleeve to the fascia.
3. Check the suture sleeve after tie-down to demonstrate stability and lack of
slippage by grasping the suture sleeve with fingers and trying to move the
lead in either direction.
Venous Cutdown Technique
1. Slide the suture sleeve into the vein past the distal groove.
2. Ligate the vein around the suture sleeve to obtain hemostasis.
3. Using the same groove, secure the lead and vein to the adjacent fascia
(Figure 11 Example of suture sleeve, venous cutdown technique on page
26).
Figure 11. Example of suture sleeve, venous cutdown technique
26
4. Use at least two grooves to secure the sleeve to the lead. Secure the lead
and suture sleeve to the adjacent fascia.
5. Check the suture sleeve after tie-down to demonstrate stability and lack of
slippage by grasping the suture sleeve with fingers and trying to move the
lead in either direction.
Tunneling the Lead
Follow these steps if tunneling the lead:
1. Allow slack on the lead for strain relief on the lateral side of the suture
sleeve near the venous entry site when securing the leads to body tissue.
This will prevent lead dislodgment caused by the weight of the pulse
generator or upper extremity movement.
Figure 12. Strain relief loop
WARNING: 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.
2. Remove the stylet and Connector Tool.
NOTE: A compatible tunneling tip is recommended for use with this lead if the
pulse generator is implanted away from the vein insertion site. Refer to the
instructions for use for the tunneling tip and/or tunneler kit if one is being used.
When using a compatible tunneling tip, do not cap the lead.
3. Cap the lead terminal if a tunneling tip and/or tunneler kit is not used. Grip
the terminal pin with a hemostat, or equivalent.
WARNING: Do not contact any other portion of the lead terminal, other than
the terminal pin, even when the lead cap is in place.
27
4. Gently tunnel the lead subcutaneously from the vein insertion site to the
implant pocket.
CAUTION: Tunnel the lead from the chest area to the pulse generator
implant site. Do not 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.
CAUTION: When tunneling the lead, take precautions not to place excessive
tension on the lead. This can cause either structural weakness and/or
conductor discontinuity.
CAUTION: 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.
NOTE: If the tunneling procedure must be delayed, cap the lead terminal and
form a temporary pocket for the coiled lead. Capping the terminal protects it
and prevents body fluids from entering the lumen of the lead.
5. Reattach the lead terminals to the pulse generator and evaluate lead
signals with the pulse generator as previously described.
• If the measurements are unacceptable, check the electrical
connections. A discontinuous or abnormal signal may indicate
dislodgment, a loose connection, or lead damage.
• If necessary, reposition the lead electrodes until acceptable values are
obtained. To reposition the lead, carefully withdraw the tunneled
portion back to the venous entry site. Release the permanent ligatures
and reposition the lead using procedures previously discussed.
POSTIMPLANT
Postimplant Evaluation
Perform follow-up evaluation as recommended in the applicable pulse
generator physician's manual.
CAUTION: 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.
WARNING: Ensure that an external defibrillator and medical personnel
skilled in CPR are present during post-implant device testing should the patient
require external rescue.
NOTE: Chronic repositioning of the lead may be difficult because of body
fluid or fibrotic tissue intrusion.
28
Explantation
NOTE: Return all explanted pulse generators and leads to Boston Scientific.
Examination of explanted pulse generators and leads can provide information
for continued improvement in system reliability and warranty considerations.
WARNING: 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.
Contact Boston Scientific when any of the following occur:
• When a product is removed from service.
• In the event of patient death (regardless of cause), along with an autopsy
report, if performed.
• For other observation or complications reasons.
NOTE: Disposal of explanted pulse generators and/or leads is subject to
applicable laws and regulations. For a Returned Product Kit, contact Boston
Scientific using the information on the back cover.
Consider the following items when explanting and returning the pulse generator
and/or lead:
• Interrogate the pulse generator and print a comprehensive report.
• Deactivate the pulse generator before explantation.
• Disconnect the leads from the pulse generator.
• If leads are explanted, attempt to remove them intact, and return them
regardless of condition. Do not remove leads with hemostats or any other
clamping tool that may damage the leads. Resort to tools only if manual
manipulation cannot free the lead.
• Wash, but do not submerge, the pulse generator and leads to remove
body fluids and debris using a disinfectant solution. Do not allow fluids to
enter the pulse generator's lead ports.
• Use a Boston Scientific Returned Product Kit to properly package the
pulse generator and/or lead, and send it to Boston Scientific.
SPECIFICATIONS
Specifications (Nominal)
Table 4. Model Number and Lead Length
Model Single Coil/Dual Coil Length
0665 Dual Coil 59 cm
0636 Dual Coil 64 cm
29
Table 4. Model Number and Lead Length (continued)
Model Single Coil/Dual Coil Length
0651 Dual Coil 70 cm
0662 Single Coil 59 cm
0663 Single Coil 64 cm
0650 Single Coil 70 cm
Table 5. Specifications (Nominal)
Characteristic Nominal
Terminal type DF4-LLHH (dual-coil models)
DF4-LLHO (single-coil models)
Compatibility Pulse generators with a DF4-LLHH
port or GDT-LLHH port, which
accepts either a DF4-LLHH or DF4LLHO terminal
Fixation Tined
Electrode:
660 mm
2
2
Distal coil surface area 450 mm
Proximal coil surface area (dual-coil
models)
Tip surface area 3.5 mm
Tip to proximal coil electrode length (dual-
2
18 cm
coil models)
Tip to distal coil electrode length 12 mm
Diameter:
Insertion 2.7 mm (8F)
Isodiametric lead body 2.4 mm (7.3F)
Material:
External insulation Silicone rubber
Terminal molding Polyurethane (75D)
Terminal pin and ring contacts MP35N™
Pace/sense conductor MP35N™
a
nickel-cobalt alloy
a
nickel-cobalt alloy,
PTFE covered
Shocking conductor Drawn filled tube cable, ETFE
coated
30
Table 5. Specifications (Nominal) (continued)
Characteristic Nominal
Tip electrode IROX (iridium oxide) coated Pt-Ir
Distal fitting electrode Titanium
Coil backfill Silicone
Steroid 0.97 mg dexamethasone acetate
Maximum Lead Conductor Resistance:
From (low voltage) terminal pin to distal tip
electrode
From (low voltage) proximal terminal ring
contact to distal coil electrode
From (high voltage) middle terminal ring
contact to distal coil electrode
From (high voltage) distal terminal ring
contact to proximal coil electrode (dual coil
models)
a. MP35N is a trademark of SPS Technologies, Inc.
80 Ω
80 Ω
2.5 Ω
2.5 Ω
Lead Introducer
Table 6. Lead introducer
Recommended lead introducer
Introducer without guide wire
a. When retaining a guide wire, a 2.5F increase in introducer size is recommended.
a
8F (2.7 mm)
Symbols on Packaging
The following symbols may be used on packaging and labeling (Table 7
Symbols on packaging on page 31):
Table 7. Symbols on packaging
Symbol Description
Reference number
Serial number
Use by
Lot number
31
Table 7. Symbols on packaging (continued)
Symbol Description
Date of manufacture
Sterilized using ethylene oxide
Do not resterilize
Do not reuse
Do not use if package is damaged
Consult instructions for use on this website: www.
bostonscientific-elabeling.com
Opening instruction
Manufacturer
32
MR Conditional
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112–5798 USA
www.bostonscientific.com
1.800.CARDIAC (227.3422)
+1.651.582.4000
©
2018 Boston Scientific Corporation or its affiliates.
All rights reserved.
350062-007 EN US 2018-07
*350062-007*
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