Durata™

Model 7120Q
Model 7121Q
Model 7122Q

Quadpole connector
Active-fixation
True bipolar
Dual-coil/Single-coil
Steroid-eluting
Endocardial
Defibrillation leads

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. © 2013 St. Jude Medical, Inc. All Rights Reserved.
Description
The Durata™ Models 7120Q, 7121Q, and 7122Q transvenous tachyarrhythmia leads are true
bipolar, steroid-eluting, active fixation leads. The Models 7120Q and 7121Q leads have two
defibrillation electrodes. The Model 7122Q lead has one defibrillation electrode. The leads are
designed for implantation with the distal tip positioned in the right ventricle. Durata leads provide
rate-sensing, pacing, and delivery of cardioversion/defibrillation shocks.
Durata Models 7120Q, 7121Q, and 7122Q leads use an extendable-retractable helix at the tip for
fixation in the ventricle. The design of the tip aids visibility under fluoroscopy. Portions of the lead
body have an Optim™ (silicone polyurethane copolymer) insulation overlay. The leads’ insulation
tubing is treated with Fast-Pass™ coating to increase lubricity. The low profile, flat-wire
defibrillation electrodes with silicone rubber backfilling are intended to preclude tissue ingrowth.
After contact with body fluid, the helix electrode elutes dexamethasone sodium phosphate (DSP),
a steroid. Steroid elution minimizes tissue inflammation, which reduces both acute and chronic
pacing thresholds.
The Durata Models 7120Q, 7121Q, and 7122Q leads have a 5 cm long (distal) defibrillation
electrode coil located 17 mm from the distal tip of the lead. The Model 7120Q and Model 7121Q
leads’ second (proximal) defibrillation coil is 8 cm long, and is located at either 17 cm
(Model 7120Q), or 21 cm (Model 7121Q) from the distal tip of the lead.
A single DF4 (quadpole, four electrical terminal) lead connector connects the electrodes to the
pulse generator for delivery of high voltage cardioversion/defibrillaQUitetion and pacing/sensing
therapies. The DF4 lead connector is compatible with device headers with a DF4-LLHH lead
receptacle designation. The DF4 lead connector connects the lead to the pulse generator for
dedicated bipolar sensing and pacing using the pacing tip as the cathode (-) and a small-surface
ring electrode as the anode (+). The DF4 lead terminal pin has an opening to accept the
positioning stylet and rotates to extend and retract the helical tip. SJ4-LLHH is equivalent to DF4-
LLHH. SJ4 and DF4 connectors comply with ISO27186:2010(E).
The lead conductors are in a multifilar coil configuration and are insulated with silicone rubber.

Figure 1. Nominal dimensions of DF4-LLHH lead connector, in mm

1. RV tip
2. RV ring
3. RV coil
4. SVC coil

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Indications for Use
The Durata™ Models 7120Q, 7121Q, and 7122Q 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 1. Accessories and their Intended use

Accessory Intended Use

Stylet Stiffen and support the lead to facilitate placement
Suture sleeve Protect the lead from damage when it is secured to the venous
entry site
Vein pick Lift and dilate the vein at the lead entry site
Lead cap Insulate and protect the lead connector when it is secured to the
venous entry site
Clip-on tool Extend and retract the helix of an active-fixation lead
IS4/DF4 connector sleeve Provide a safe and secure connection and disconnection to the
lead connector

Contraindications
Contraindications for use of the Durata™ 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. Durata
leads are contraindicated for patients for whom a single dose of 1.0 mg of dexamethasone sodium
phosphate is contraindicated. Durata leads are contraindicated for use with extra firm (red color
knob) stylets.
The lead is not designed, sold, or intended for use other than as indicated.

Lead Package Contents

All leads are packaged separately and supplied sterile. Package contents are as follows:
 1 lead with stylet and suture sleeve in place
 1 vein pick
 2 clip-on tools
 Stylets of varying firmness
 IS4/DF4 connector sleeve
 Product documentation

2
Potential Complications
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, post-operative heart
failure, chronic mechanical stimulation of the heart, tricuspid valve dysfunction, lead fracture
necessitating surgical removal, pneumothorax, hemothorax, infection, tissue necrosis, and erosion
of the skin. Specific events and effects are summarized in the Table below.

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 complications and precautions specific to the pulse
generator.

Table 2. Potential Complications

Event Possible Effects

Dislodgement, breaching of the lead Intermittent or continuous loss of sensing, possibly
insulation, connector fracture, poor resulting in nondetection of arrhythmia; oversensing of
connection to the pulse generator, artifact, possibly causing inappropriate delivery of therapy
electrode fracture, or conductor from the pulse generator; intermittent or continuous loss of
discontinuity. 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, or hemorrhage
Venous perforation Acute hemorrhage (may not be readily apparent) or cardiac
tamponade
Myocardial irritability Premature ventricular contractions, supraventricular and
ventricular tachyarrhythmias
Transvenous implantation procedure Air embolism
Chronic implantation Venous thrombosis and/or obstruction
Contamination Infection requiring removal of lead system, pulse generator,
or both
Post-shock rhythm disturbances Post-shock bradycardia or supraventricular arrhythmias
Threshold elevation or exit block Loss of efficacy of defibrillation, cardioversion, or pacing
therapy
Shunting or insulating of current Increased external defibrillation energy and/or repositioning
during defibrillation with internal or of paddles required
external paddles

3
Implantation Procedure
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. 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.

4
 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 sure the
valve allows for appropriate passage of the lead without damaging the lead
body.
 To avoid distortion of the Durata™ lead tip, do not use a St. Jude Medical™
Seal-Away™ hemostasis

Preparing the Lead

Test the extension and retraction of the helix before implanting the lead:
1. Insert a stylet into the lead, if necessary, and 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 DF4 connector pin into the first notch. Place the
clip-on tool on the larger diameter surface of the connector pin. 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. Release the handles of the tool so that it grasps the DF4 connector pin firmly.
4. While keeping the lead as straight as possible, grasp the DF4 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.) 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.
1. 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 lead helix mechanism.

2. To remove the clip-on tool, pinch the handles and withdraw the DF4 connector pin from the
tool.

Selecting and Accessing a Vein

The suggested entry site is the left cephalic vein entered utilizing a venous cutdown. Alternatively,
the lead may be implanted percutaneously through the left subclavian vein. However, studies1
indicate that the incidence of lead damage may be decreased with the lead placed by cephalic
vein cutdown. 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). Venous access may be obtained using the right subclavian or the internal jugular vein.

1
Magney, 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, [Link], D.M.,
Fink, A.S., Miller, R.P., et al.: Anatomical and Morphological Evaluation of Pacemaker Lead Compression. PACE 16 (I): 434-444,
1993.

5
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
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 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.
- 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.
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
not placed in the coronary sinus or in a retrograde position, and that the entire distal
defibrillation coil is below the tricuspid valve.
6. 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

6
 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.

7. Once the desired fixation site has been located, hold the lead body stationary in one hand
and attach the clip-on tool to the DF4 connector pin.
For instructions on using the clip-on tool, see Preparing the Lead (page 5).
8. While keeping the lead as straight as possible, grasp the DF4 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 (see below).
For instructions on using the clip-on tool, see Preparing the Lead (page 5).

Figure 2. Helix retraction and extension

1. Helix fully retracted

2. Helix fully extended

CAUTION
Do not rotate the connector pin after the helix is fully extended or retracted. Doing
so may damage the helix mechanism.

9. 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
may be evaluated with the stylet still in place

10. Verify that the helix is fixed by pulling gently on the lead and checking for resistance.
11. If the lead is properly fixated, 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 when
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.
12. Verify proper lead placement by measuring the sensed R-wave amplitude and determining

7
 the pacing threshold.
Refer to the appropriate pulse generator manual for recommended procedures and 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
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.

8
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
should 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.
Refer to the appropriate pulse generator manual for recommended test procedures and
acceptable values for defibrillation voltage and high-voltage lead impedance.
Ensure that the stylet has been withdrawn from the implanted lead. When appropriate, induction
and termination of ventricular tachycardia using antitachycardia pacing or cardioversion should
also be performed.
If the tested configuration does not provide effective defibrillation, the lead should be repositioned
or another lead configuration should be chosen and repeat testing 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 is recommended that this be performed 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 (shown 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

9
 sleeve. The most distal groove may be used to tie off the vein over the suture sleeve.

Figure 6. Suturing 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 non-absorbable suture (shown above).

If desired, a second suture sleeve may be utilized for additional security:

1. Carefully open the slit in the sleeve and position the sleeve on the lead body.
2. 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.
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 high-voltage 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 2.

1. 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.

2
Furman S, Hayes DL, Holmes DR: A Practice of Cardiac Pacing. 3rd ed. New York: Futura Publishing, Inc.; 1993:[Link],
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; 1955:613-615.

10
 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.

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.

11
Technical Support
St. Jude Medical Cardiac Rhythm Management Division 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 are used on the lead labels.

Table 3. Symbols

Symbol Description
LLHH Quadrapolar connector (low voltage, low voltage, high voltage,
high voltage)
LLHO Quadpole connector (low voltage, low voltage, high voltage,
open)
Authorized EC Representative in the European Community

Sterilized using ethylene oxide

Caution, Consult Accompanying Documents

Date of Manufacture

Country of manufacture; BE- Belgium, MY- Malaysia, US- United

States
Do not reuse

Manufacturer

Serial number

Temperature limitations

Use by

Affixed in accordance with European Council Directive

90/385/EEC and 1999/5/EC. Hereby, St. Jude Medical declares
that this device is in compliance with the essential requirements
and other relevant provisions of these Directives.

12
Cardiac Rhythm Management Division

Manufacturer: European Authorized Representative: Australian Sponsor:

St. Jude Medical St. Jude Medical St. Jude Medical Australia Pty. Limited
Cardiac Rhythm Coordination Center BVBA 17 Orion Road
Management Division The Corporate Village Lane Cove NSW 2066
15900 Valley View Court Da Vincilaan 11 Box F1 Australia
Sylmar, CA 91342 USA 1935 Zaventem
+1 818 362 6822 Belgium
+32 2 774 68 11

Manufacturing Site: Manufacturing Site:

St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd.
Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa,
Santana Industrial Park Bayan Lepas Industrial Zone
Arecibo, PR 00612 11900 Penang
USA Malaysia

[Link]

April 2013
Art 60044493/A