St. Jude Medical Optisure LDA220 User manual

Optisure™
Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, LDP230Q
Quadpole connector/IS-1 and DF-1 connector
Active-fixation/Passive-fixation
True bipolar
Dual-coil/Single-coil
Steroid-eluting
Endocardial
Defibrillation leads
User's Manual

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the
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d birth defects or other reproductive harm. For more information, go to
www.P65Warnings.ca.gov.
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, LLC and its related companies.
Pat.
http://patents.sjm.com
©
2017 St. Jude Medical, LLC. All Rights Reserved.

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Description
Optisure™Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, and LDP230Q 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 and LDA210Q which have one. The leads provide true bipolar rate-sensing,
pacing, and delivery of cardioversion/defibrillation shocks.
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, and LDP230Q, 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. Models LDA210 and LDA210Q 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 long-term
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 dexamethasone sodium phosphate (DSP), a
steroid. This minimizes tissue inflammation, which, in turn, is intended to reduce both acute and
chronic pacing thresholds. For models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, and
LDA210Q, the target dose of DSP in the monolithic controlled release device (MCRD) is
491 micrograms.
For models LDP220, LDP230, LDP220Q, and LDP230Q, the target dose of DSP in the MCRD is
324 micrograms and a target dose of DSP in the tip electrode coating is 121 micrograms. The
total dose of DSP for these models is 445 micrograms.
For information on the specifications of any lead model, refer to the following tables.
Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Length (cm) 60, 65, 75 52, 58, 65
Lead introducer (Fr) 8
Electrode
configuration:
Tip electrode helix
Ring electrode cylindrical
Defibrillation
electrode
trifilar coil
Electrode spacing:
Tip to ring
electrode (mm)
11

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Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Tip to distal
defibrillation
electrode (mm)
17
Tip to proximal
defibrillation
electrode (cm)
17 21 n/a 17 21 n/a
Connector type1
Sense/pace 1 IS-1 bipolar (3.2 mm) connector n/a
Defibrillation 2 DF-1 unipolar (3.2
mm) connectors
1 DF-1
unipolar(3.2
mm)
connector
n/a
Sense/pace/
defibrillation
n/a DF4-
LLHH
DF4-
LLHH
DF4-
LLHO
Materials
2
Body Fast-Pass™
Conductors 35N LT and 35N LT DFT
Connectors MP35N and stainless steel MP35N
Insulators silicone rubber, Optim™, ETFE, and PTFE
Defibrillation
electrodes
platinum iridium alloy
Pacing electrode
(helix)
titanium nitride-coated platinum iridium alloy
Steroid-eluting plug DSP
Electrode surface area (mm2):
Pacing tip 6
Pacing ring 17
Distal defibrillation 367
Proximal
defibrillation
638 638 n/a 638 638 n/a
Electrode length:
Pacing tip (mm) 1.80
Pacing ring (mm) 2.79
Distal defibrillation
(cm)
5
Proximal
defibrillation (cm)
8 8 n/a 8 8 n/a
Electrical resistance (Ω):
1St. 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.
2MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.

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Table 1. Active fixation lead technical specifications
LDA220
LDA230
LDA210
LDA220Q
LDA230Q
LDA210Q
Pace 60 cm: 17
65 cm: 18
75 cm: 21
52 cm: 15
58 cm: 17
65 cm: 19
Sense 15 < 6
Defibrillation < 6
Maximum diameter
(mm)
2.54 at defibrillation electrodes
Maximum helix
revolutions
20
Table 2. Passive fixation lead technical specifications
LDP220
LDP230
LDP220Q
LDP230Q
Length (cm) 60,65,75 52,58,65
Lead introducer (Fr) 8
Electrode configuration:
Tip electrode semispherical shape
Ring electrode cylindrical
Defibrillation electrode trifilar coil
Electrode spacing:
Tip to ring electrode
(mm)
11
Tip to distal defibrillation
electrode (mm)
17
Tip to proximal
defibrillation electrode
(cm)
17 21 17 21
Connector type3
Sense/pace 1 IS-1 bipolar(3.2 mm)
connector
n/a
Defibrillation 2 DF-1 unipolar(3.2 mm)
connectors
n/a
Sense/pace/defibrillation n/a DF4-LLHH
Materials4
Body Fast-Pass™
Conductors 35N LT and 35N LT DFT
Connectors MPS35N and stainless steel MPS35N
Insulators silicone rubber, Optim™, ETFE, and PTFE
3St. 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.
4MP35N is a trademark of SPS Technologies. 35N LT and 35N LT DFT are registered trademarks of Fort Wayne Metals.

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Table 2. Passive fixation lead technical specifications
Defibrillation electrodes platinum iridium alloy
Pacing electrode titanium nitride-coated platinum iridium alloy
Steroid-eluting plug dexamethasone sodium phosphate
Electrode surface area (mm
2
):
Pacing tip 3.5
Pacing ring 17
Distal defibrillation 367
Proximal defibrillation 638
Electrode length:
Pacing tip (mm) 0.45
Pacing ring (mm) 2.41
Distal defibrillation (cm) 5
Proximal defibrillation
(cm)
8
Electrical resistance (Ω):
Pace 60 cm: 33
65 cm: 36
75 cm: 42
52 cm: 29
58 cm: 32
65 cm: 36
Sense 15 < 6
Defibrillation < 6
Maximum diameter (mm) 2.54 at defibrillation electrodes

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Figure 1. Optisure Models LDA220/LDA230 lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Distal defibrillation electrode
4. Proximal defibrillation electrode
5. Suture sleeve
6. Lead body trifurcation
7. IS-1 connector boot
8. Sense/pace connector (IS-1 bipolar, 3.2 mm)
9. Defibrillation connectors (DF-1, 3.2 mm)

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Figure 2. Optisure Model LDA210 lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Defibrillation electrode
4. Suture sleeve
5. Lead body trifurcation
6. IS-1 connector boot
7. Sense/pace connector (IS-1 bipolar, 3.2 mm)
8. Defibrillation connector (DF-1, 3.2 mm)
Figure 3. Optisure Models LDA220Q/LDA230Q lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Distal defibrillation electrode
4. Proximal defibrillation electrode
5. Suture sleeve
6. DF4 connector

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Figure 4. Optisure Model LDA210Q lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Defibrillation electrode
4. Suture sleeve
5. DF4 connector
Figure 5. Optisure Models LDP220/LDP230 lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Distal defibrillation electrode
4. Proximal defibrillation electrode
5. Suture sleeve
6. Lead body trifurcation
7. IS-1 connector boot
8. Sense/pace connector (IS-1 bipolar, 3.2 mm)
9. Defibrillation connectors (DF-1, 3.2 mm)

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Figure 6. Optisure Models LDP220Q/LDP230Q lead
1. Tip electrode (cathode)
2. Ring electrode (anode)
3. Distal defibrillation electrode
4. Proximal defibrillation electrode
5. Suture sleeve
6. DF4 connector
Indications
The Optisure™Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, and LDP230Q 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.
Contraindications
Optisure™Models LDA220, LDA230, LDA210, LDA220Q, LDA230Q, LDA210Q, LDP220,
LDP230, LDP220Q, and LDP230Q leads are contraindicated in the following:
Patients with tricuspid valvular disease or a mechanical tricuspid valve.
Patients with ventricular tachyarrhythmias resulting from transient or correctable factors
such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
Patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is
contraindicated.
For use with extra firm (red color knob) stylets (models LDA220, LDA230, LDA210,
LDA220Q, LDA230Q, and LDA210Q).
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.
Use only battery-powered equipment when implanting and testing the lead to avoid

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fibrillation caused by alternating current.
Ground all line-powered equipment used near the patient to avoid fibrillation caused by
alternating current.
Insulate lead connector pins from potential leakage currents from line-powered equipment to
avoid fibrillation caused by the leakage current.
Precautions
Do not tie a ligature directly to the lead body, tie it too tightly on the suture sleeve, or
otherwise create excessive strain at the insertion site as this may damage the lead.
Do not grip the lead with surgical instruments as this may damage the lead.
Use the same polarity evaluated during testing when connecting the lead to the pulse
generator to ensure defibrillation efficacy.
If a thoracotomy is required to place epicardial patches, it should be done during a separate
procedure to reduce the risk of morbidity and mortality.
If countershock is unsuccessful using external paddles, adjust the external paddle position,
for example, anterior-lateral to anterior-posterior.
Do not severely bend or kink stylets or leads as this may damage the lead.
Keep the stylets clean and free from blood, tissue, or other debris to reduce any potential for
the stylet sticking or binding within the lead body.
Do not use excessive force or surgical instruments to insert a stylet into a lead as this may
damage the lead.
Withdraw the stylet after placing the lead to prevent potential malfunction of the lead.
Use only St. Jude Medical™suture sleeves to immobilize and protect the lead against
damage from ligatures.
Do not place the lead near another implanted lead to ensure sensing and defibrillation
efficacy.
Do not rotate the connector pin after the helix is fully extended or retracted as doing so may
damage the lead.
To avoid distortion of the Optisure™lead tip, do not use a St.Jude Medical™Seal-Away™
hemostasis valve.
Adverse Events in the Durata™ Models 7120Q, 7121Q,
7122Q, 7170Q Leads
The Optisure™leads are similar to the Durata™leads except for increased Optim™insulation
thickness in the proximal region of the lead and the addition of Optim™insulation underneath the
SVC defibrillation coil. The clinical data presented in this document were collected on the Durata™
7120Q, 7121Q, 7122Q, and 7170Q lead models that are part of a clinical study (SJ4 Post
Approval Study– PMA File Number P950022/S042). The purpose of the clinical study, which
included Durata™7120Q, 7121Q, 7122Q and 7170Q lead models, was to evaluate the safety and
effectiveness of the SJ4 system (device with DF4 connector and RV high voltage DF4 leads). SJ4
is equivalent to DF4. The Q-version of the Durata™lead models are identical to the non-Q version
except for the type of connector.
As of the interim 3 year report (data cut-off date– June 29, 2012), the SJ4 system clinical trial
involved 1697 patients with implanted systems and 3624.92 cumulative implant years. Two-
hundred forty-one patients expired during the course of the clinical study. An independent Events

10
Committee felt that none of these deaths were attributable to the Durata™lead. One-hundred sixty
additional patients were withdrawn from the study for reasons listed in the following table. The
reasons for withdrawal excludes withdrawals for deaths or unsuccessful implants.
Table 3. Summary of Withdrawals
Reason for withdrawal
Number of patients
Heart Transplant 2
Patient and/or family request 80
Patient lost to follow-up 17
Patient non-compliance 8
Patient participation terminated by investigator 23
System Explant 30
Total
160
Observed Adverse Events
The observations and complications reported from this clinical study as of the 4 year interim
report are summarized in the following table. For the purposes of this discussion, a complication
is defined as a clinical event with potential adverse effects that require invasive intervention to
treat or resolve. Observations are those clinical events with potential adverse effects that do not
require invasive intervention. A total of 55 complications were reported in 50 patients and 30
observations were reported in 29 patients. The RV lead or DF4 connector related complication
rate at 30 months for Durata™7120Q, 7121Q, 7122Q, and 7170Q leads was 2.9%.
Table 4. Observed Adverse Events
# Pts with AEs
(n = 1697)
% of Pts with
AEs
# of AEs
AE/pt-years (n
= 3624.92)
Abnormal Lead Defibrillation
Impedance >= 100 Ohms
1 0.1% 1 0.000
Elevated ventricular pacing
thresholds
6 0.4% 7 0.002
Failure to Detect VT/VF 1 0.1% 1 0.000
Migration 31 1.8% 33 0.009
Lead Fracture 3 0.2% 3 0.001
Loss of Capture 2 0.1% 2 0.001
Perforation 6 0.4% 6 0.002
Undersensing 2 0.1% 2 0.001
Complications (total)
505
2.9%
55
0.015
Abnormal Lead Defibrillation
Impedance <= Ω
1 0.1% 1 0.000
Abnormal Lead Defibrillation 6 0.4% 6 0.002
5Some patients experienced more than one event and therefore the number of patients is less than the number of events.

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Table 4. Observed Adverse Events
# Pts with AEs
(n = 1697)
% of Pts with
AEs
# of AEs
AE/pt-years (n
= 3624.92)
Impedance >= 100
Ω
Elevated pacing thresholds 9 0.5% 9 0.002
High DFTs 1 0.1% 1 0.000
Lead bent at implant 1 0.1% 1 0.000
Migration 3 0.2% 3 0.001
Loss of Capture 3 0.2% 3 0.001
Oversensing 4 0.2% 4 0.001
Undersensing 2 0.1% 2 0.001
Observations (total)
296
1.5%
30
0.008
Potential Adverse Events
Possible adverse events associated with the use of transvenous lead systems include, but are not
limited to, those summarized in the following table.
Refer to the appropriate pulse generator manual for additional complications and precautions
specific to the pulse generator.
Table 5. Potential Adverse Events
Event
Possible Effects
Dislodgement, breaching of the lead
insulation, connector fracture, poor
connection to the pulse generator,
electrode fracture, or conductor
discontinuity.
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.
Cardiac perforation Intermittent or continuous loss of sensing, cardiac
tamponade, hemorrhage, pneumothorax, or loss of
contractility
Venous perforation Acute hemorrhage (may not be readily apparent),
hemothorax, pneumothorax, or cardiac tamponade
Myocardial irritability Premature ventricular contractions, supraventricular
and ventricular tachyarrhythmias, postoperative heart
failure
Transvenous implantation procedure Air embolism
Chronic (> 3 months) implantation Venous thrombosis and/or obstruction, tissue necrosis,
6The total number of patients with complications is the total number of patients who experienced at least one complication listed
above. The same applies for the total number of patients with observations.

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Table 5. Potential Adverse Events
Event
Possible Effects
skin erosion, tricuspid valve dysfunction, chronic
mechanical stimulation of the heart
Contamination Infection requiring removal of lead system, pulse
generator, or both
Post-shock rhythm disturbances Post-shock bradycardia or supraventricular
arrhythmias, conduction disturbances
Threshold elevation or exit block Loss of efficacy of defibrillation, cardioversion, or
pacing therapy
Shunting or insulating of current during
defibrillation with internal or external
paddles
Increased external defibrillation energy and/or
repositioning of paddles required
Clinical Studies in the Durata™ Models 7120Q, 7121Q,
7122Q, 7170Q Leads
The Optisure™leads are similar to the Durata™leads except for increased Optim™insulation
thickness in the proximal region of the lead and the addition of Optim™insulation underneath the
SVC defibrillation coil. The clinical data presented in this document were collected on the Durata™
7120Q, 7121Q, 7122Q, and 7170Q lead models that are part of a clinical study (SJ4 Post
Approval Study). The purpose of the clinical study, which included Durata™7120Q, 7121Q,
7122Q and 7170Q lead models, was to evaluate the safety and effectiveness of the SJ4 system
(device with DF4 connector and RV high voltage SJ4 leads). SJ4 is equivalent to DF4. The Q-
version of the Durata™lead models are identical to the non-Q version except for the type of
connector.
Patients Studied
As of the 3 years interim report (data cut-off date–June 29, 2012), 1697 patients were implanted
with the SJ4 system in the clinical trial. Patient enrollment began on June 4, 2009 and was
completed on July 13, 2010. Patients in this study will have a 5 year follow-up period from
implant. Refer to the following table for patient follow-up status as of the interim report. The
population was predominantly male (71.7%) with a mean age of 65 years.
Table 6. Patient follow-up status
Visit Type
Expected at this
Visit (N)
Followed
Through
(Showed Up) at
this Visit % (N)7
Withdrawals Not
Due to
Unsuccessful
Implants or
Deaths
Not Yet Due at
this Visit (N)
Implant 1697 100.0% (1697) 0 0
6 month 1591 93.1% (1521) 42 0
12 month 1497 91.1% (1432) 75 0
7The denominator is the total number of expected visits plus withdrawals not due to death or unsuccessful implants.

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18 month 1407 87.4% (1323) 107 0
24 month 1251 84.5% (1170) 134 89
30 month 514 73.5% (492) 155 787
36 month 20 11.1% (20) 160 1276
Methods
The primary objective of the SJ4 clinical study was to characterize the chronic performance of the
SJ4 System (device with DF4 connector and RV high voltage DF4 leads). The primary endpoints
were complication free survival at 5 years for complications related to the RV lead or DF4
connector and electrical performance (capture threshold) of the high voltage RV lead.
The following data related to RV leads was collected starting at implant and every 6 months
thereafter, until 60 months (5 years): complications and observations, capture thresholds, pacing
lead impedances, defibrillation lead impedances, and sensing amplitudes.
Results
The RV lead capture thresholds, R-wave amplitude, RV lead pacing lead impedance at implant
and follow-up visits up to 36 months as of the interim report are summarized in the following
table.
Table 7. Summary of pace/sense measurements at implant and follow-up visits up to 36 months
Visit Type
RV Lead Capture
Threshold @ 0.5 ms
Pulse Width
RV Lead Pacing
Impedance
R-wave
Amplitude8
IMPLANT
Mean ± SD Range
(n=1689)
0.60 ± 0.28 V
0.25 to 5.00 V
(n=1697)
566 ± 137 Ω
230 to 1600 Ω
(n=1625)
9.8 ± 2.6 mV
0.5 to 12.0 mV
6 month
Mean ± SD
Range
(n=1494)
0.80 ± 0.49 V
0.25 to 7.00 V
(n=1521)
465 ± 91 Ω
210 to 1075 Ω
(n=1460)
10.2 ± 2.6 mV
0.3 to 12.0 mV
12 month
Mean ± SD
Range
(n=1413)
0.82 ± 0.44 V
0.25 to 7.50 V
(n=1432)
452 ± 91 Ω
260 to 910 Ω
(n=1372)
10.2 ± 2.6 mV
0.5 to 12.0 mV
18 month
Mean ± SD
Range
(n=1304)
0.84 ± 0.44 V
0.25 to 6.50 V
(n=1323)
446 ± 92 Ω
250 to 1075 Ω
(n=1269)
10.1 ± 2.6 mV
0.5 to 12.0 mV
24 month
Mean ± SD
Range
(n=1159)
0.85 ± 0.47 V
0.25 to 7.50 V
(n=1170)
441 ± 96 Ω
250 to 1100 Ω
(n=1079)
10.1 ± 2.6 mV
0.5 to 12.0 mV
8Values submitted that were greater than 12 mV were excluded from analysis because St. Jude Medical devices truncate R-wave
signal amplitudes to 12. The device reports any R-wave amplitude greater than 12 mV as “>12 mV”.

14
Table 7. Summary of pace/sense measurements at implant and follow-up visits up to 36 months
Visit Type
RV Lead Capture
Threshold @ 0.5 ms
Pulse Width
RV Lead Pacing
Impedance
R-wave
Amplitude8
30 month
Mean ± SD
Range
(n=489)
0.87 ± 0.38 V
0.25 to 4.00 V
(n=491)
435 ± 91 Ω
260 to 790 Ω
(n=464)
10.0 ± 2.7 mV
0.5 to 12.0 mV
36 month
Mean ± SD
Range
(n=20)
0.78 ± 0.23 V
0.50 to 1.25 V
(n=20)
442 ± 79 Ω
310 to 610 Ω
(n=18)
10.6 ± 2.6 mV
1.3 to 12.0 mV
Instructions for Use
Personnel Training
Because of the nature of the lead implantation procedure, physicians should be familiar with all
components of the system and the contents of this manual before beginning the procedure. St.
Jude Medical provides physicians with comprehensive, on-site training and support. Topics
include:
Lead handling
Lead configurations
Lead positioning
Lead testing
Lead suturing and fixation
Required Equipment
Equipment for cardiac monitoring, fluoroscopic imaging, external defibrillation, and measuring
lead signals should be available for immediate use during lead implantation and 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. Inspect the package carefully before opening and check the "Use
Before" date on the product label. If the lead package and seal are intact, the lead and
accompanying components are ready to use. 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.
Verify that the sterility indicator on the inner package is not purple. Purple indicates that the
package has not been sterilized.
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.

15
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
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 will not tolerate excessive
bending or stretching.
CAUTION
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 when handling the lead, or remove talc 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.
Note
Do not immerse the helix electrode in liquid or wipe it with any liquid as this may
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.

16
CAUTION
If using a percutaneous lead introducer with a hemostasis valve, make 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.
Using the Stylets
CAUTION
To avoid damaging the lead or body tissue, do not use excessive force or
surgical instruments to insert a stylet into a lead.
When handling a stylet, avoid severe bending, kinking, or blood contact.
Accumulated blood or other debris on the stylet may hinder its passage into or
removal from the lead and make future insertion of stylets impossible.
Try to keep the lead straight when inserting a stylet; do not insert a stylet into a
severely bent lead.
While removing a stylet, hold the lead at the connector end with the lead
straight to avoid stress on the lead body.
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.

17
Figure 7. Using the clip-on tool
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.
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.
5. 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.
6. 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. However, studies9
indicate that the incidence of lead damage may be decreased with the lead placed by cephalic
9Magney, J.E., Flynn, D. M., Parsons, J.A., et al.: Anatomical Mechanisms Explaining Damage to Pacemaker Leads, Defibrillator
Leads, and Failure of Central Venous Catheters Adjacent to the Sternoclavicular Joint. PACE 16 (I): 445-457, 1993.Jacobs, D.M.,
Fink, A.S., Miller, R.P., et al.: Anatomical and Morphological Evaluation of Pacemaker Lead Compression. PACE 16 (I): 434-444,
1993.

18
vein cutdown or, if a percutaneous subclavian entry is chosen, with a puncture site 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 is included in the package to aid in inserting the lead into the vein. Its use is optional
and depends on the implantation technique chosen.
To use the vein pick:
1. Isolate and open the selected vein with scissors or a scalpel.
2. 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.
3. Raise and tilt the vein pick gently, and pass the lead tip under the pick into the vein lumen.
CAUTION
Do not use the vein pick for puncturing the vein, dissecting tissue during
cutdown, or manipulating the lead.
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. Under fluoroscopic guidance and with the helix retracted, advance the lead into the right
atrium.
2. 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
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.
3. Under close fluoroscopic monitoring, advance the curved lead/stylet through the tricuspid
valve and into the ventricular chamber.
4. 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.
5. 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