Download User`s Manual - St. Jude Medical Instructions for Use Website

Optisure™
Defibrillation leads
Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, LDP230Q, LDP210Q
User's Manual
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or
one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service
marks of St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights
Reserved.
Description
Optisure™ Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, LDP230Q, and LDP210Q transvenous tachyarrhythmia leads are
steroid-eluting, active or passive fixation leads, and are designed for long-term attachment to
an implantable cardioverter defibrillator (ICD). All leads have two defibrillation electrodes
except for models LDA210, LDA210Q, and LDP210Q which have one. The leads provide true
bipolar rate-sensing, pacing, and delivery of cardioversion/defibrillation shocks.
Certain Optisure models and lead lengths have been tested for use in the MRI environment
and are designated MR Conditional. See MR Conditional ICD System (page 5).
All models are designed for implantation with the distal tip positioned in the right ventricle. For
models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, and LDA210Q, the tip incorporates
an extendable/retractable helix for fixation in the ventricle. The retractable helix allows the
electrical testing of possible lead positions prior to advancement of the fixation helix. The
design of the tip aids visibility under fluoroscopy. For models LDP220, LDP230, LDP220Q,
LDP230Q, and LDP210Q, the tip of the lead has tines for fixation in the ventricle. The low
profile, flat-wire defibrillation electrodes with silicone rubber backfilling are intended to
preclude tissue ingrowth.
Models LDA220, LDA230, LDA220Q, LDA230Q, LDP220, LDP230, LDP220Q, and LDP230Q
are quadripolar leads and models LDA210, LDA210Q, and LDP210Q are tripolar leads.
Portions of the lead body have an Optim™ (silicone polyurethane copolymer) insulation
overlay. The lead body insulation tubing is Optim™ insulation and silicone rubber for longterm biocompatibility and biostability. The lead body is treated with Fast-Pass™ coating to
provide lubricity during lead implant.
After contact with body fluid, the tip electrode elutes an amount less than 1.0 milligram of
dexamethasone sodium phosphate (DSP), a steroid. This minimizes tissue inflammation,
which, in turn, is intended to reduce both acute and chronic pacing thresholds.
For information on the specifications of any lead model, refer to the following tables.
Figure 1. Nominal dimensions of DF4-LLHH lead connector (mm)
1.
2.
3.
4.
RV tip
RV ring
RV coil
SVC coil
Table 1. Active fixation lead technical specifications
Length (cm)
LDA220 LDA230 LDA210
LDA220Q
60, 65, 75
52, 58, 65
1
LDA230Q LDA210Q
Table 1. Active fixation lead technical specifications
LDA220 LDA230 LDA210
Lead introducer (Fr) 8
Electrode configuration:
helix
Tip electrode
Ring electrode
cylindrical
Defibrillation
electrode
Electrode spacing:
trifilar coil
Tip to ring
electrode (mm)
11
Tip to distal
defibrillation
electrode (mm)
17
Tip to proximal
defibrillation
electrode (cm)
Connector type 1
17
Sense/pace
Defibrillation
Sense/pace/
defibrillation
Materials 2
21
n/a
LDA220Q
LDA230Q LDA210Q
17
21
n/a
DF4LLHH
DF4LLHO
1 IS-1 bipolar (3.2 mm)
n/a
connector
2 DF-1 unipolar
1 DF-1
n/a
(3.2 mm)
unipolar(3.2
connectors
mm)
connector
n/a
DF4LLHH
Body
Fast-Pass™
Conductors
35N LT and 35N LT DFT
Connectors
MP35N and stainless steel
Insulators
silicone rubber, Optim™, ETFE, and PTFE
Defibrillation
electrodes
platinum iridium alloy
Pacing electrode
(helix)
titanium nitride-coated platinum iridium alloy
MP35N
DSP
Steroid-eluting
plug
Electrode surface area (mm2):
6
Pacing tip
Pacing ring
17
1
St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1
lead connectors conform to the international connector standard ISO 11318/Amd. 1.
MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.
2
2
Table 1. Active fixation lead technical specifications
Distal
defibrillation
Proximal
defibrillation
Electrode length:
Pacing tip (mm)
LDA220 LDA230 LDA210
367
LDA220Q
LDA230Q LDA210Q
638
638
n/a
638
638
n/a
8
n/a
8
8
n/a
1.80
Pacing ring (mm) 2.79
5
Distal
defibrillation (cm)
8
Proximal
defibrillation (cm)
Electrical resistance (Ω):
60 cm: 17
Pace
65 cm: 18
75 cm: 21
15
Sense
Defibrillation
Maximum diameter
(mm)
Maximum helix
revolutions
52 cm: 15
58 cm: 17
65 cm: 19
<6
<6
2.54 at defibrillation electrodes
20
Table 2. Passive fixation lead technical specifications
LDP220
Length (cm)
Lead introducer (Fr)
Electrode configuration:
LDP230
60,65,75
8
semispherical shape
Ring electrode
cylindrical
Tip to ring electrode
(mm)
LDP230Q LDP210Q
52,58,65
Tip electrode
Defibrillation electrode
Electrode spacing:
LDP220Q
trifilar coil
11
Tip to distal defibrillation 17
electrode (mm)
17
Tip to proximal
defibrillation electrode
(cm)
21
17
3
21
n/a
Table 2. Passive fixation lead technical specifications
LDP220
LDP230
LDP220Q
LDP230Q LDP210Q
Connector type 3
1 IS-1 bipolar(3.2 mm)
connector
2 DF-1 unipolar(3.2
Defibrillation
mm) connectors
Sense/pace/defibrillation n/a
Sense/pace
n/a
n/a
DF4-LLHH DF4LLHH
DF4-LLHO
Materials 4
Body
Fast-Pass™
Conductors
35N LT and 35N LT DFT
Connectors
Insulators
MP35N and stainless
MP35N
steel
silicone rubber, Optim™, ETFE, and PTFE
Defibrillation electrodes
platinum iridium alloy
Pacing electrode
titanium nitride-coated platinum iridium alloy
dexamethasone sodium phosphate
Steroid-eluting plug
Electrode surface area (mm2):
3.5
Pacing tip
Pacing ring
17
Distal defibrillation
367
Proximal defibrillation
Electrode length:
638
Pacing tip (mm)
0.45
Pacing ring (mm)
2.41
Distal defibrillation (cm)
5
Proximal defibrillation
(cm)
Electrical resistance (Ω):
Pace
Sense
Defibrillation
Maximum diameter (mm)
8
638
638
638
n/a
8
8
8
n/a
60 cm: 33
65 cm: 36
75 cm: 42
15
52 cm: 29
58 cm: 32
65 cm: 36
<6
<6
2.54 at defibrillation electrodes
3
St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841-3. St. Jude Medical DF-1
lead connectors conform to the international connector standard ISO 11318/Amd. 1.
4
MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.
4
Indications
The Optisure™ Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q,
LDP220, LDP230, LDP220Q, LDP230Q, and LDP21OQ transvenous leads are indicated for
use with compatible pulse generators (refer to the applicable defibrillator manual for system
indications). They provide pacing and sensing and deliver cardioversion/defibrillation therapy
to the heart.
A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for
lead implantation. If the initial lead configuration is not effective, repositioning of the lead or
other lead configurations should be attempted.
In some patients, a nonthoracotomy lead configuration may not provide reliable conversion of
arrhythmias, and the use of subcutaneous or epicardial patch defibrillation leads should be
considered.
Table 3. Accessories and their intended uses
Accessory
Intended use
Insulate and protect the lead connector when it is not
connected to a device.
Stylet
Stiffen and support the lead to facilitate placement.
Protect the lead from damage when it is secured to the
Suture sleeve
venous entry site.
Vein pick
Lift and dilate the vein at the lead entry site.
Stylet guide (funnel, IS-1 models Assist the insertion of the stylet into the lead connector pin
only)
to facilitate placement.
Clip-on tool
Extend and retract the helix of an active-fixation lead.
DF-1 plug (single coil model
Seal unused lead receptacles.
only)
Provide a safe and secure connection and disconnection
IS4/DF4 connector sleeve
to the lead.
Lead cap
Contraindications
Contraindications for use of the Optisure™ leads with an implantable pulse generator include
ventricular tachyarrhythmias resulting from transient or reversible factors such as drug
toxicity, electrolyte imbalance, or acute myocardial infarction. Transvenous lead systems are
contraindicated for patients with tricuspid valvular disease or a mechanical heart valve.
Optisure™ leads are contraindicated for patients for whom a single dose of 1.0 mg of
dexamethasone sodium phosphate is contraindicated. Optisure™ leads are contraindicated
for use with extra firm (red color knob) stylets for active fixation lead models.
The lead is not designed, sold, or intended for use other than as indicated.
MR Conditional ICD System
The St. Jude Medical™ MR Conditional lead is part of the St. Jude Medical MR Conditional
ICD system.
An MR Conditional lead is conditionally safe for use in the MRI environment when used in a
complete MR Conditional ICD system and according to the instructions in the MRI Procedure
5
Information document for the St. Jude Medical™ MR Conditional ICD System.
Patients with an implanted St. Jude Medical MR Conditional ICD system can have an MRI
scan if the conditions for use, as described in the MRI Procedure Information document, are
met.
The following models and lead lengths have been tested and determined to be MR
Conditional when used according to the instructions in the MRI Procedure Information
document. Models and lead lengths marked not listed in the table below have not been tested
and their use in an MR environment is not determined.
Table 4. MR Conditional models and lead lengths for Optisure leads
Model
LDA210Q
LDA210Q
LDA220Q
LDA220Q
Lead Length
58
65
58
65
MR Status
MR Conditional
MR Conditional
MR Conditional
MR Conditional
Warnings and Precautions


Testing has demonstrated that the St. Jude Medical™ MR Conditional ICD system is
conditionally safe for use in the MRI environment when used according to the
instructions in the MRI Procedure Information document.
Models and lead lengths not listed in the table MR Conditional ICD System (page 5)
have not been tested and its use in an MR environment is not determined.
Package Contents
The lead is packaged separately and supplied sterile. Packages contain:

1 lead with stylet and suture sleeve in place

1 vein pick

2 clip-on tools (active fixation models only)

Stylets of varying firmness

1 stylet guide (funnel, IS-1 models only)

1 DF-1 plug (single coil model only)

Product documentation

IS4/DF4 connector sleeve
Storage
The lead should be stored at room temperature. Permitted storage temperatures are between
-5°C (23°F) and +50°C (122°F).
Potential Adverse Events
Possible complications of the use of transvenous lead systems include, but are not limited to,
supraventricular or ventricular arrhythmias, conduction disturbances, cardiac perforation,
cardiac tamponade, loss of contractility, air embolism, heart wall rupture, myocarditis, postoperative heart failure, chronic mechanical stimulation of the heart, tricuspid valve
dysfunction, lead fracture necessitating surgical removal, pneumothorax, hemothorax,
6
infection, tissue necrosis, and erosion of the skin. Specific events and effects are summarized
in the following table.
WARNING
Implanted cardiac leads are subjected to a hostile environment within the
body due to constant, complex flexural and torsional forces, interactions with
leads and/or the pulse generator, or other forces associated with cardiac
contractions and patient physical activity, posture, and anatomical
influences. Cardiac leads’ functional lifetimes can be affected by these and
other factors.
Refer to the defibrillator manual for additional system complications and precautions as well
as those specific to the pulse generator.
Table 5. Potential Adverse Events
Event
Dislodgement, breaching of the lead
insulation, connector fracture, poor
connection to the pulse generator,
electrode fracture, or conductor
discontinuity.
Cardiac perforation
Venous perforation
Myocardial irritability
Transvenous implantation procedure
Chronic implantation
Contamination
Post-shock rhythm disturbances
Threshold elevation or exit block
Shunting or insulating of current during
defibrillation with internal or external
paddles
Possible Effects
Intermittent or continuous loss of sensing, possibly
resulting in nondetection of arrhythmia; oversensing
of artifact, possibly causing inappropriate delivery of
therapy from the pulse generator; intermittent or
continuous loss of defibrillation, cardioversion, or
pacing therapy; possible muscle or nerve stimulation
in the pocket area; intermittent or continuous loss of
cardioversion/defibrillation therapy, sensing, or
pacing therapies.
Intermittent or continuous loss of sensing, cardiac
tamponade, or hemorrhage
Acute hemorrhage (may not be readily apparent), or
cardiac tamponade
Premature ventricular contractions, supraventricular
and ventricular tachyarrhythmias
Air embolism
Venous thrombosis and/or obstruction
Infection requiring removal of lead system, pulse
generator, or both
Post-shock bradycardia or supraventricular
arrhythmias
Loss of efficacy of defibrillation, cardioversion, or
pacing therapy
Increased external defibrillation energy and/or
repositioning of paddles required
Instructions for Use
Required Equipment
Equipment for cardiac monitoring, fluoroscopic imaging, external defibrillation, and measuring
lead signals should be available for immediate use during lead implantation and
7
tachyarrhythmia induction testing. Additional quantities of all sterile implantable devices
should be available in case of accidental contamination or damage.
Package Inspection
St. Jude Medical packages all leads under clean conditions and sterilizes them using
ethylene oxide gas before shipment. If the lead package and seal are intact, the lead and
accompanying components are ready to use. Inspect the package carefully before opening
and check the “Use Before” date on the product label.
Verify that the sterility indicator on the inner package is not purple. Purple indicates that the
package has not been sterilized. Do not use the lead if there appears to be damage to the
package or the lead. If the package is wet, damaged, or punctured, or if the seal is broken,
contact St. Jude Medical.
St. Jude Medical does not recommend use of the product after its expiration date. If the lead
package has been breached outside a sterile field or the expiration date has passed, contact
St. Jude Medical.
Sterilization


The package contents have been sterilized with ethylene oxide before shipment. This
lead is for single use only and is not intended to be resterilized.
If the sterile package has been compromised, contact St. Jude Medical.
Handling the Lead






Use caution when handling the lead. It is designed to be pliable, but it will not tolerate
excessive bending or stretching. Permanent damage to the lead may result from severe
bending, kinking, or stretching, or from excessive manipulation with surgical instruments.
Never apply pressure to the lead with a surgical instrument, such as a hemostat.
Do not try to alter electrodes or apply pressure to the tips of electrodes.
Avoid contact of the electrode with a hard surface and guard against contaminating the
lead tip with insulating materials such as lubricants or medical adhesive.
Use powderless surgical gloves or be sure that talc has been removed from surgical
gloves before handling the lead. Because lead insulation attracts particulate matter such
as lint and dust, minimize contamination by protecting the lead from materials that shed
such particles.
Do not immerse the helix electrode in liquid or wipe it with any liquid as this will reduce
the amount of DSP eluted after implantation.
Implantation Procedure
Implantation of a transvenous lead generally involves:

Selecting, isolating, and opening the desired vein.

Inserting the lead using the vein pick and stylets.

Positioning and securing the lead.

Testing the sensing, pacing, and cardioversion/defibrillation functions of the lead.

Suturing the lead in place.

Connecting the lead to the pulse generator
Techniques for implantation vary among physicians and depend on the patient's anatomy and
physical condition. The following description presents a typical technique; other methods may
also be applicable.
CAUTION
 If using a percutaneous lead introducer with a hemostasis valve, make
8
sure the valve allows for appropriate passage of the lead without
damaging the lead body.
 To avoid distortion of the Optisure™ lead tip, do not use a St. Jude
Medical™ Seal-Away™ hemostasis valve.
Stylet Guide (Funnel, IS-1 models only)
Use the stylet guide (funnel) to assist the insertion of a stylet into the lead's IS-1 connector
pin. Insert the stylet guide over the IS-1 connector pin prior to introducing the stylet.
Preparing the Active Fixation Lead
Test the extension and retraction of the helix before implanting the lead.
1.
Insert a stylet into the lead, if necessary. Verify that the stylet is fully inserted.
2.
Straighten the lead on a flat surface.
3.
Pinch the clip-on tool open and insert the connector pin into the first notch. For DF4
leads only, place the clip-on tool on the larger diameter surface of the connector pin. For
all leads, make sure the clip-on tool remains in this position on the connector pin when
you rotate the clip-on tool to extend the helix and release the handles of the tool so that
it grasps the connector pin firmly.
4.
While keeping the lead as straight as possible, grasp the connector boot with one hand
and with the other hand, rotate the clip-on tool clockwise to extend the helix. (Refer to
the Technical Specifications tables for the number of rotations required to extend the
helix.) The helix is fully extended when at least 2 turns are visible beyond the lead tip.
5.
6.
CAUTION
While extending or retracting the helix:
 Keep the lead as straight as possible. Bending or kinking the lead body
may interfere with the helix movement or cause damage to the lead.
 Do not grasp the lead body. Doing so may interfere with the helix
movement or cause damage to the lead.
Rotate the clip-on tool counter-clockwise to retract the helix.
CAUTION
Do not further rotate the connector pin after the helix is fully extended or
retracted. Doing so may damage the helix mechanism.
To remove the clip-on tool, pinch the handles and withdraw the connector pin from the
tool.
Selecting and Opening a Vein
The suggested entry site is the left cephalic vein entered through a venous cutdown.
Alternatively, the lead may be implanted percutaneously through the left subclavian vein.If a
percutaneous subclavian entry is chosen, the puncture site should be as lateral as possible
(in the area under the lateral two-thirds of the clavicle, lateral to the subclavius muscle). The
right subclavian vein and the internal jugular vein can also be used.
Inserting the Lead
A vein pick included in the package is intended to aid in inserting the lead into the vein. Its
use is optional and depends on the chosen implantation technique.
To use the vein pick, first isolate and open the selected vein with scissors or a scalpel. Orient
the point of the vein pick in the direction the lead will be passed and insert the point through
the incision into the vessel lumen. Raise and tilt the vein pick gently, and pass the lead under
the pick into the vein lumen.
Do not use the vein pick for puncturing the vein, dissecting tissue during cutdown, or
9
manipulating the lead.
Extra stylets are packaged with each lead.
To avoid damage to the lead or to body tissue, do not use excessive force or surgical
instruments to insert a stylet into a lead.
Attempt to keep the lead straight when inserting a stylet; do not insert the stylet into a
severely bent lead. Hold the lead at the connector end with the lead straight while removing
the stylet to avoid stress on the lead body.
Keep the stylet clean and free of blood and tissue contact. Accumulated blood and/or tissue
on the stylet may hinder its passage into or removal from the lead and make future insertion
of stylets impossible.
Positioning the Active Fixation Lead
Confirm that the helix is completely retracted before implantation. When the helix is
completely retracted, the helix tip might extend slightly beyond the lead tip.
Note
If blood clogs the helix, repositioning may require a greater number of pin rotations
to extend the helix. Repeated repositioning attempts may impair the helix extension
mechanism.
1.
2.
3.
4.
5.
6.
7.
Under fluoroscopic guidance and with the helix retracted, advance the lead into the right
atrium.
To aid in passing the lead through the tricuspid valve and into the right ventricle:
remove the stylet from the lead
-
shape the distal end of the stylet into a gentle curve
-
carefully reinsert the stylet into the lead
-
To avoid damage to the stylet and lead, do not attempt to curve the stylet while it is
inserted in the lead. Do not use a sharp object to curve the distal end of the stylet.
Under close fluoroscopic monitoring, advance the curved lead/stylet through the
tricuspid valve.
Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves
or penetrating the heart muscle when it continues down into the ventricle.
Continue to advance the lead. When the tip reaches position in the right ventricle, retract
the stylet an additional ten centimeters or more.
Accurate electrode positioning is vital for stable sensing and pacing. Verify that the lead
tip is not placed in the coronary sinus or in a retrograde position, and that the entire
distal defibrillation coil is below the tricuspid valve.
If desired, evaluate one or more potential fixation sites using the helix tip prior to
extending the helix.
Refer to the appropriate pulse generator manual for the recommended procedures and
values for measuring the sensed R-wave amplitude.
CAUTION
Do not place the lead near another implanted lead. Such close proximity
could result in the electrodes making contact with each other and cause
electrical interference.
Once the desired fixation site has been located, hold the lead body stationary in one
hand and attach the clip-on tool to the connector pin.
For instructions on using the clip-on tool, see Preparing the Active Fixation Lead (page
9).
10
8.
While keeping the lead as straight as possible, grasp the connector boot with one hand
and with the other hand, rotate the clip-on tool clockwise to extend the helix. (Refer to
the Technical Specifications sheet for the number of rotations required to extend the
helix.)
When viewed under fluoroscopy, the helix is fully extended when at least 2 turns are
visible beyond the lead tip (Figure 2).
Figure 2. Extension and retraction of the helix
1.
2.
3.
4.
9.
10.
11.
Helix fully extended
Helix fully retracted
Marker ring
Electrically active helix
CAUTION
Do not rotate the connector pin after the helix is fully extended or retracted.
Doing so may damage the helix mechanism.
Under fluoroscopy, verify that the helix is extended, then carefully withdraw the stylet
while observing the lead's position.
CAUTION
The stylet must be withdrawn before defibrillation testing to prevent potential
malfunction of the lead. However, the sensing and pacing functions of the
lead can be evaluated with the stylet still in place.
Verify that the helix is fixed by pulling gently on the lead and checking for resistance.
If the lead is properly fixed, resistance will be felt and the lead will remain in place. A
poorly affixed lead will come loose easily and must then be repositioned.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or
the patient breathes deeply or stretches. At the same time for dual-coil leads, ensure
that there is not an excess of slack which may allow the proximal electrode to contact
the tricuspid valve.
Verify proper lead placement by measuring the sensed R-wave amplitude and
determining the pacing threshold.
Refer to the appropriate pulse generator manual for recommended procedures and
acceptable values.
Note
For DF4 leads, use a sterile patient cable with a plunger clip (such as Models 4160
or 4161) or the IS4/DF4 Connector Sleeve (Model EX3151). The use of alligator
clips directly on the lead is not recommended because they may damage the lead.
Positioning the Passive Fixation Lead
1.
Under fluoroscopic guidance, advance the lead into the right atrium.
2.
To aid in passing the lead through the tricuspid valve and into the right ventricle:
11
3.
4.
5.
6.
7.
8.
-
remove the stylet from the lead
-
shape the distal end of the stylet into a gentle curve
-
carefully reinsert the stylet into the lead
The flexibility of the lead's distal defibrillation coil allows the distal end of the lead to
conform to the shape of the stylet.
CAUTION
To avoid damage to the stylet and lead, do not attempt to curve the stylet
while it is inserted in the lead. Do not use a sharp object to curve the distal
end of the stylet.
Under close fluoroscopic monitoring, advance the curved lead/stylet through the
tricuspid valve and into the ventricular chamber.
Pull the stylet back a few centimeters to reduce the risk of the lead damaging the valves
or penetrating the heart muscle when it continues down into the ventricle.
Continue to advance the lead. When the tip reaches position in the right ventricle, retract
the stylet an additional ten centimeters or more.
Accurate electrode positioning is vital for stable sensing and pacing. Verify that the lead
tip is not placed in the coronary sinus or in a retrograde position, and that the entire
distal defibrillation coil is below the tricuspid valve.
CAUTION
Do not place the lead near another implanted lead. Such close proximity
could result in the electrodes making contact with each other and cause
electrical interference.
Under fluoroscopic guidance, carefully withdraw the stylet while observing the lead's
position.
CAUTION
The stylet must be withdrawn before defibrillation testing to prevent potential
malfunction of the lead. However, the sensing and pacing functions of the
lead can be evaluated with the stylet still in place.
Verify that the tined tip is well fixed in a stable position in the trabeculae of the ventricle
by pulling back gently on the lead while observing its position under fluoroscopy.
If the lead is properly fixed, resistance will be felt and the lead will remain in place. A
poorly affixed lead will come loose easily and must then be repositioned.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or
the patient breathes deeply or stretches. At the same time, ensure that there is not an
excess of slack which may allow the proximal electrode to contact the tricuspid valve.
Verify proper lead placement by measuring the sensed R-wave amplitude and
determining the pacing threshold.
Refer to the appropriate pulse generator manual for recommended procedures and
acceptable values.
Note
For DF4 leads, use a sterile patient cable with a plunger clip (such as Models 4160
or 4161) or the IS4/DF4 Connector Sleeve (Model EX3151). The use of alligator
clips directly on the lead is not recommended because they may damage the lead.
IS4/DF4 Connector Sleeve
The IS4/DF4 connector sleeve is designed for use with an IS4 or a DF4 lead. It provides a
safe and secure connection and disconnection to the lead connector.
1.
Insert the IS4 or the DF4 lead into the IS4/DF4 connector sleeve until the lead cannot be
12
inserted any further.
Figure 3. Inserting the lead into the connector sleeve
1. Contact clips
2. Lead connector pin
3. Connector ring electrodes
2.
Verify the connector ring electrodes are visible in each of the contact clip windows.
Figure 4. Connector ring electrodes displayed in the contact clip windows
3.
Attach all alligator clips to the appropriate connector ring electrodes.
Figure 5. Attaching the alligator clips
Note
Remove alligator clips prior to removing the connector sleeve from the lead.
Testing Defibrillation Efficacy
Once acceptable sensing and pacing performance have been verified, defibrillation lead
testing may be performed to determine the voltage/energy requirements for reliable
defibrillation, and to ensure that those requirements are well within the output capabilities of
the pulse generator.
13
If defibrillation is performed, ensure that the stylet has been withdrawn from the implanted
lead.
If the tested configuration does not provide effective defibrillation, the lead may be
repositioned or another lead configuration may be chosen and repeat testing may be
performed. In some patients, however, no lead configuration may provide reliable
defibrillation, and the use of an alternative lead system should be considered.
Note
If a thoracotomy is required, it should be done during a separate procedure.
Suturing the Lead
After acceptable lead performance is verified by testing, the position of the lead should be
secured using the suture sleeve to prevent dislodgement or migration. The suture sleeve will
protect the lead insulation and conductor coil against damage from ligatures:
1.
Position the suture sleeve to place it near, against, or just inside the vein.
2.
Ensure that excess slack in the lead body is removed before suturing by viewing the
position of the lead under fluoroscopy.
Allow enough slack in the lead so that it is not under tension as the heart contracts, or
when the patient breathes deeply or stretches.
3.
Using heavy, nonabsorbable suture on the distal groove, secure the suture sleeve to the
vein. Tie the suture firmly but gently to avoid damaging the lead as shown in the figure
below.
4.
Use the proximal groove to secure the suture sleeve to the fascia and to the lead by first
creating a base by looping heavy, nonabsorbable suture through the fascia underneath
the groove and tying a knot. Tie sutures firmly around each available groove on the
suture sleeve. The most distal groove may be used to tie off the vein over the suture
sleeve.
Figure 6. Suture the lead
1. Vein
2. Fascia
3. Lead body
CAUTION
Damage to the lead insulation, damage to the coil, and impairment of lead
function may result from failure to use suture sleeves, tying the ligatures too
tightly, or otherwise creating excessive strain at the insertion site. Never tie a
ligature directly to the lead body. Be careful not to dislodge the lead tip
during suturing. Always use heavy, nonabsorbable suture.
If desired, a second suture sleeve may be utilized for additional security:
14
1.
2.
Carefully open the slit in the sleeve and position the sleeve on the lead body.
Follow the procedure (above) to suture and secure the sleeve.
Connecting the Lead to the Pulse Generator
To prevent damage to the lead, avoid the use of excessive force on the lead body or
connector. To avoid dislodgement or potential fracture, do not put the lead under extreme
tension or flexion. Do not apply pressure to the lead with a surgical instrument.
1.
CAUTION
Orient the excess lead length and the pulse generator to minimize the
potential for insulation damage resulting from lead-to-lead or pulse
generator-to-lead interaction. For example, minimize the potential for leads
lying on top of each other under the pulse generator and ensure that there
are no sharp bends in the lead. Lead insulation damage can result in
electrical current arcing to the pulse generator, thereby damaging the highvoltage circuitry, or creating an alternate electrical current path which may
result in compromised therapy delivery. Current practice indicates that a
subcutaneous pocket is preferred over a subpectoral pocket. 5 6
Before the lead is connected to the pulse generator, the position of the lead should be
reviewed under fluoroscopy, and the R-wave amplitude and pacing threshold
measurements should be repeated to verify that the lead has not become dislodged or
damaged.
Refer to the pulse generator manual for the configuration of the ports on each model.
CAUTION
Grasp the lead as close as possible to the connector while inserting the lead
connector straight into the pulse generator port. If necessary, regrip the lead
and continue to insert the lead connector until it is fully seated in the pulse
generator port.
2.
Connect the lead, carefully pushing the lead connector all the way into the pulse
generator ports. Verify visually through the clear top of the pulse generator that the lead
connector has been pushed in completely and can be seen protruding behind the port
connector.
Be sure that the setscrew is tightened before implanting the device.
3.
To avoid twisting the lead body, loosely roll excess lead length under the pulse
generator before placing the excess lead and the generator in the subcutaneous pocket.
In order to avoid stressing the lead conductors and insulation, the pulse generator
should not be implanted in the subcutaneous pocket with the lead attached to the ports
at a sharp angle.
When placing the pulse generator and the lead into the subcutaneous pocket, do not grip the
lead or the pulse generator with surgical instruments. Use of excessive force or improper
instruments on the lead body or connector during pulse generator placement can cause
damage affecting the long-term reliability of the connector and impairment of its function.
After connection of the lead to the pulse generator, test the function of the lead with the pulse
generator to ensure sensing, pacing, and cardioversion/defibrillation efficacy.
5
Furman S, Hayes DL, Holmes DR. A Practice of Cardiac Pacing. 3rd ed. New York: Futura Publishing, Inc.; 1993:286-289.
Belott, PH, Reynolds, DW. Permanent Pacemaker and Implantable Cardioverter-Defibrillator Implantation. In: Ellenbogen
KA, Kay GN, Wilkoff BL, eds. Clinical Cardiac Pacing and Defibrillation. 2nd ed. Philadelphia, Pa: WB Saunders; 1995:613615.
6
15
Post-Implantation Follow-Up
St. Jude Medical strongly recommends pre-discharge and chronic follow-up electrophysiology
studies, including induction of ventricular fibrillation, in order to verify the long-term
performance of the lead system. Follow-up chest x-rays to verify the position of the lead are
also recommended. It is also recommended that repeat testing be performed if the patient’s
clinical status or antiarrhythmic drug therapy has changed.
Removing Chronically Implanted Leads
Cap any abandoned lead and secure the lead cap with sutures to prevent unwanted
transmission of electrical signals from the electrode to the heart. Seal the remaining open end
of any severed lead with medical adhesive and a lead cap. Suture the remnant to adjacent
tissue using heavy, nonabsorbable suture to prevent migration of the lead fragment into the
heart.
If the lead or any portion of it is extracted, handle it according to local regulations. Clean the
extracted lead with disinfectant and return it to St. Jude Medical for investigation and safe
disposal. For safety reasons, it is recommended that all used leads be enclosed in a
protective cover.
Please complete an Out of Service/Explant/Patient Death form and return it to St. Jude
Medical with the extracted lead. Whenever possible, send along a printout of the programmed
settings of the pulse generator.
Accessories
Table 6. Accessories available for use with the products described in this manual
Clip-on tool (active fixation models only)
DF-1 plug (single coil model only)
Lead cap
Stylets
Stylet guide (funnel, IS-1 models only)
Suture sleeve
Vein pick
IS4/DF4 connector sleeve
Stylet Color Codes
Table 7. Stylet color codes
Knob Color
Light green
Green
Yellow
Description
Extra-soft straight (40 mm taper)
Soft straight (20 mm taper)
Firm straight
16
Diameter
0.014 in/0.36 mm
0.014 in/0.36 mm
0.015 in/0.38 mm
Technical Support
St. Jude Medical maintains 24-hour phone lines for technical questions and support:

1 818 362 6822

1 800 722 3774 (toll-free within North America)

+ 46 8 474 4147 (Sweden)
For additional assistance, call your local St. Jude Medical representative.
Symbols
The following symbols may be found on the product or product label:
Symbol
Description
DF4-LLHH
Quadrapolar connector (low voltage, low voltage, high voltage, high
voltage)
DF4-LLHO
Quadpole connector (low voltage, low voltage, high voltage, open)
Active fixation, Extendable/Retractable
Steroid-eluting
Not to be used when a single dose of 1.0 mg dexamethasone sodium
phosphate is contraindicated
Contains less than 1.0 mg dexamethasone sodium phosphate
Minimum introducer size
Optim lead insulation overlay with Fast-Pass coating
Endocardial
Defibrillation lead
One lead
Authorized EC Representative in the European Community
Sterilized using ethylene oxide
Accessories
Product literature
Contents
Caution, Consult Accompanying Documents
17
Symbol
Description
Consult instructions for use
Follow instructions for use on this website
Date of Manufacture
Reorder number
Country of manufacture; BE- Belgium, MY- Malaysia, US- United
States
Do not use if package is damaged
Do not reuse
Manufacturer
Serial number
Temperature limitations
Prescription only
Use by
Device has been demonstrated to pose no known hazards in a
specified MRI environment with specified conditions of use.
Affixed in accordance with European Council Directive 90/385/EEC.
Hereby, St. Jude Medical declares that this device is in compliance
with the essential requirements and other relevant provisions of these
Directives.
Made in USA
18
Cardiac Rhythm Management Division
Manufacturer:
St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
+1 818 362 6822
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
sjm.com
August 2015
Art 60066360/B
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia