St. Jude Medical Tendril MRI LPA1200M User manual

Tendril MRI™
Model LPA1200M
User's Manual
Active Fixation
Bipolar
Steroid-Eluting
Endocardial
Pacing Lead

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. © 2014 St. Jude Medical, Inc. All Rights Reserved.

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Description
The Tendril MRI™ lead, Model LPA1200M, is an MR Conditional (page 1), bipolar, steroid-eluting, active fixation implantable pacing
lead with Optim™ insulation.
The lead can be placed in either the right atrium or the right ventricle.
Features of Tendril MRI lead include:
Soft tip header — reduces lead tip pressure
Optim insulation — a silicone-polyurethane copolymer
Marker ring — to facilitate optimal lead positioning
Active fixation — features a rotating, extendable/retractable helix for secure anchoring
Steroid elution — contains a monolithic controlled-release device (MCRD), located in the tip electrode of the lead, which is
impregnated with dexamethasone sodium phosphate (DSP). The steroid (DSP) decreases the inflammatory reaction of the heart
during the acute stage (0-3 months post implant) of patient recovery.
Note
Tendril MRI low-polarization bipolar leads are compatible with the AutoCapture™ pacing system contained in St. Jude
Medical™ devices.
Intended Use/Indications
The Tendril MRI™ lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination
with a compatible device.
Active leads such as the Tendril MRI lead may be indicated for patients where permanent fixation of passive leads is suspected to be
unstable.
In atrial applications, the use of a screw-in lead such as Tendril MRI lead may be indicated in the presence of an abnormal,
surgically altered or excised atrial appendage.
This is an MR Conditional (page 1) lead.
Table 1. Accessories and their intended uses
Accessory
Intended use
Clip-on tool Extend and retract the helix of an active-fixation lead.
Lead cap Insulate and protect the lead connector when it is not connected to a pulse
generator.
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 lifter Lift and dilate the vein at the lead entry site.
Contraindications
The Tendril MRI™lead is contraindicated:
in the presence of tricuspid atresia
for patients with mechanical tricuspid valves
in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.
MR Conditional Pacing System
The St. Jude Medical™ MR Conditional lead is part of the St. Jude Medical MR Conditional pacing system.
Patients with an implanted St. Jude Medical™ MR Conditional pacing system can have an MRI scan if the conditions for use, as
described in the MRI Procedure Information document, are met.
Warnings and Precautions
Warnings
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

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physical activity, posture, and anatomical influences. Cardiac leads' functional lifetimes can be affected by these and other
factors.
Exercise extreme caution when testing leads.
Use only battery-powered equipment during lead implantation and testing to protect against fibrillation which may be induced
by alternating current.
Use only properly grounded line-powered equipment in the vicinity of the patient during the implant procedure.
Insulate lead connector pins from any leakage currents that may arise from line-powered equipment.
Avoid diathermy, even if the device is programmed off, as it may damage tissue around the implanted electrodes or may
permanently damage the pulse generator.
Testing has demonstrated that the St. Jude Medical™ MR Conditional pacing system is conditionally safe for use in the MRI
environment when used according to the instructions in the MRI Procedure Information document. The St. Jude Medical MR
Conditional pacing system includes a St. Jude Medical MR Conditional pulse generator connected to one or more St. Jude
Medical MR Conditional leads.
"Untested" indicates that the device has not been tested and its use in an MR environment is not determined. For more
information, please consult the MRI Procedure Information document.
Precautions
For single use only.
Before opening the lead package, confirm that it is compatible with the device to be implanted
Carefully remove the tip retainer from the lead prior to implantation.
Handling
The lead conductor and its insulating sheath may be damaged if subjected to extreme mechanical stress.
Do not stretch, crush, kink, or bend the lead as leads may be damaged by improper handling before and during implant or by
excessive mechanical stress post-implantation.
Do not bring the lead into contact with sharp objects which could puncture or otherwise compromise the insulation.
Avoid handling the lead with any surgical tools such as hemostats, clamps, or forceps.
Avoid touching or handling the lead tip electrode.
Do not immerse the lead body in mineral oil, silicone oil, alcohol, or any liquid other than sterile saline or injectable fluid.
Do not immerse the tip electrode in any fluid prior to implantation; immersion of the electrode may cause a small amount of
steroid to be prematurely eluted.
Implantation
Lead implantation should be performed only when proper emergency facilities for cardioversion and/or defibrillation are
available.
Do not slide the suture sleeve over the electrode ring(s), as this could cause damage to the lead.
If subclavian venipuncture is used for lead introduction, it is important to insert the lead as lateral as possible when gaining
entry of the lead into the vein.
Perforation of the atrial or ventricular wall may cause phrenic nerve stimulation, diaphragmatic stimulation, or in some
instances, cardiac tamponade. Phrenic nerve or diaphragmatic stimulation may also be a result of lead position.
Failure to use the suture sleeve to anchor the lead may result in lead dislodgement or damage to the lead's insulation and/or
conductor coil (see Securing the Lead).
The manipulation of any hardware in the vascular system should be performed only under continuous fluoroscopic monitoring.
Pay close attention to the handling of the helix extension/retraction mechanism before and during implantation.
Packaging
Package Contents
The contents of the package are sterile. Each package contains:
One lead
One radiopaque suture sleeve attached to lead
One spare suture sleeve
One vein lifter
Two clip-on tools
One tip retainer (to be removed prior to implant)
Stainless steel stylets with knob colors designating degree of firmness.
One literature packet.

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Figure 1. Lead Accessories
1. Vein lifter
2. Clip-on tool
Storage
The lead should be stored at room temperature. Permitted storage temperatures are between -5°C (23°F) and +50°C (122°F).
Outer Package
The lead is delivered in a cardboard package. The package label contains valuable descriptive information, including model
designation, serial number, and the " Use Before" date for implantation.
Before opening, verify: (1) the package has not been damaged, punctured or otherwise compromised, (2) the lead contained is
suitable for your application. Do not implant if the "Use Before" date has expired.
Note
The lead and its accessories should be kept inside their sterile package until implantation.
Inner Package
Inside the cardboard box is an outer tray containing a sterilized inner tray. The inner tray contains the lead and its accessories.
In order to preserve sterility, operating room procedures should be followed when opening the outer tray.
CAUTION

Only a person prepared for the sterile field may handle the sterile inner tray.

Use only powderless, sterile surgical gloves when handling the lead.
Tear the label off the tray to reveal the sealed inner tray. When ready, tear open the inner tray.
Figure 2. A person not prepared for the sterile field may open the outer tray
1. Unsterile field

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Figure 3. Only a person prepared for the sterile field may open the inner tray
1. Inside sterile field
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.
Potential Adverse Events
Potential complications associated with the use of the lead are the same as with the use of any lead and listed in the following table.
Table 2. Potential Adverse Events
Event
Possible effect
Perforation of the myocardium Rupture of the heart muscle wall, "heart block", temporary or permanent loss of
stimulation and/or sensitivity, stimulation of muscles or nerves, pericardial rub.
Cardiac tamponade.
Stimulation of the phrenic nerve The lead may need to be moved from the side wall
Dislodgement of the electrode tip or a break
in the electrical conductor
Temporary or permanent loss of stimulation and/or sensing
Irritation of the heart muscle Fibrillation
Transvenous introduction Air embolism
Increased threshold level Loss of stimulation
Infection It may become necessary to perform surgical intervention to remove the lead.
Valve damage
It may become necessary to perform surgical intervention to repair the damaged valve.
Tissue necrosis It may become necessary to perform surgical intervention to remove the lead.
Damage to vessels It may become necessary to perform surgical intervention to remove the lead and/or
repair the damaged vessel.
Implanting the Lead
The following sections describe various stages of lead implantation. Procedures included in these sections are only
recommendations. Actual implant procedures are left to the discretion of the implanting physician.
It is best to keep the lead and its accessories inside the sterile package until they are to be used.
CAUTION
Pacing leads should only be implanted in conjunction with continuous fluoroscopic monitoring.

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Pre-Implantation
Before implanting the lead:
confirm compatibility between the device and the lead and review the implantation instructions
select an appropriate venous route
select and install an appropriate stylet
test the mechanical function of the helix
confirm the helix is completely retracted before implantation.
Select and Access a Vein
The suggested entry site is the left cephalic vein entered via a venous cutdown. Alternatively, the lead may be implanted
percutaneously via the left subclavian vein. However, studies1indicate that the incidence of lead damage may be decreased with the
lead placed by cephalic 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 may also be used.
The Fixation Tool
Selected St. Jude Medical™ stylet kits2include a simple fixation tool designed to insert and secure the stylet in the lead and to allow
extension and retraction of the helix.
The tool is made up of two linked pieces. The proximal (white) portion contains a thumbscrew which holds the stylet in place. The
distal (gray) portion contains a thumbscrew which secures the fixation tool to the lead's marker ring.
To use the fixation tool, attach the terminal lead pin into the distal (gray) portion of the tool, then insert the stylet through the proximal
(white) portion. While holding the fixation tool in one hand, use the other hand to unscrew/screw the fixation tool to the connector
pin.
Inserting and Removing the Stylet
The lead comes packaged with a straight stylet (light green knob) inserted into the lead.
Note
The stylet should be removed before testing the lead for mechanical stability or making intraoperative measurements.
To remove the stylet from the fixation tool, unscrew the proximal thumbscrew on the tool by turning it counterclockwise and
withdrawing the stylet.
Figure 4. Unscrew the proximal thumbscrew on the fixation tool before you withdraw the stylet
To replace the stylet, insert it into the fixation tool and tighten the proximal thumbscrew. The stylet should be inserted into the lead
before the lead is inserted into the vein.
1Magney, 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.
2For additional information, contact your St. Jude Medical Sales Representative.

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Figure 5. Insert the stylet into the fixation tool
Test the Mechanical Operation of the Helix with the Fixation Tool
Before implanting the lead, the mechanical operation of the helix should be tested.
With both thumbscrews secured and with the fixation tool in one hand, hold the lead stationary with the other hand.
Use the thumb and forefinger to rotate only the gray portion of the tool clockwise (in the direction of the arrow on the tool marked
"FIXATE").
Check to see if the helix extends from the lead tip. The helix is considered fully extended when two turns are visible beyond the
lead's marker ring.
Figure 6. Extend the helix by rotating the fixation tool clockwise
Retract the helix by holding the lead body stationary in one hand and turning only the gray portion of the tool counterclockwise
(opposite the direction indicated by the arrow "FIXATE").
Figure 7. Retract the helix by rotating the fixation tool counterclockwise

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Test the Mechanical Operation of the Helix with the Clip-On Tool
For information on using the clip-on tool, see Secure the Tip with the Clip-On Tool (page 8).
Using the Vein Lifter
A vein lifter is supplied to facilitate the introduction of the lead into a free-standing vein. Insert the tip of the vein lifter into the vein
incision and gently lift it while introducing the lead underneath, into the vein.
Figure 8. Vein lifter
Using the Lead Introducer
If a lead introducer is used, follow the instructions provided with the introducer.
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.

Be certain the vein lifter does not puncture the silicone rubber insulation of the lead. This could prevent proper
lead function.

Do not use excessive force while inserting the stylet.

When subclavian venipuncture is used for lead introduction, it is important to insert the lead as lateral as
possible during entry of the lead into the vein.

Avoid positioning the lead so that it becomes sharply bent or subjected to tension.

Do not grip the lead with surgical instruments.

Do not leave a lead unconnected in a patient unless the lead is capped.
Position the Lead
Confirm that the helix is completely retracted before implantation. This will prevent the lead from being caught in the vein during lead
introduction.
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.
Atrial Lead Placement
1. Using a straight (green or light green knob) stylet, introduce the lead into the atrium so that it rests on the floor of the atrial
chamber.
2. Replace the straight stylet with a J-shaped (green knob) stylet, or withdraw the existing stylet, bend it into a soft J-shape, and
reinsert the curved stylet into the lead.
3. As the stylet approaches the electrode tip, introduce more lead to ensure that the tip remains in the atrium as the lead takes its
"J" shape.
4. Retract the lead as necessary to ensure that the electrode tip slides into the atrial appendage. Observe the fluoroscopy monitor
to verify that the "J" is straightening.
5. When the lead tip is past the appendage and in the chamber, feed more lead into the heart so that it regains its "J" shape.
6. Take a firm grip on the stylet, then introduce more of the lead so that the electrode tip goes as far as possible into the atrium.
On fluoroscopy, the electrode tip will "tilt over" as proof that it can go no further.

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Figure 9. Atrial lead placement
7. With the clip-on tool or the fixation tool, extend the helix so that the lead is fixed to the atrial wall.
8. Retract the entire stylet from the lead with a smooth and steady motion.
9. Check that the lead is properly anchored by introducing more of it into the heart until the loop that forms either lies on the
bottom of the atrium, or is about to enter the inferior vena cava or the right ventricle. Retract any excess lead until it acquires
the correct "J" shape.
10. Ask the patient to breathe deeply and check that the lead keeps its "J" shape.
11. Ask the patient to cough to ensure that the electrode is securely anchored.
Ventricular Lead Placement
1. Advance the lead into the atrium.
2. 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.
3. Continue to advance the lead. When the tip reaches the apex, retract the stylet an additional ten centimeters or more.
4. With the clip-on tool or the fixation tool, extend the helix to fix the lead tip to the ventricular wall. If the tip is correctly secured,
the lead will be felt to jerk slightly.
5. Remove the stylet completely. Adjust the lead so that it lies in the desired position in the ventricle.
Figure 10. Ventricular lead placement
Secure the Tip with the Clip-On Tool
The lead is packaged with the clip-on tool only.
Insert the stylet into the lead and pinch open the clip-on tool. Place the lead terminal pin into the open notch of the clip-on tool so
that the pin snaps into place and release the handles. Rotate the clip-on tool clockwise to extend the helix. To remove the clip-on
tool, pinch it together and withdraw it from the lead connector.

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Figure 11. Open the clip-on tool
1. Insert lead into notch
Figure 12. Extend the helix by rotating the clip-on tool clockwise
Secure the Tip with the Fixation Tool
As an alternative to the clip-on tool, the fixation tool may be used to extend or retract the helix.
After the fixation site has been selected, hold the lead body stationary in one hand and turn the distal (gray) section of the fixation
tool clockwise (in the direction marked "FIXATE"). See the enclosed specification sheet for the approximate number of turns required
for each lead length. On the fluoroscopic image, the helix will be extended beyond the marker ring.
When two turns of the helix extend past the marker ring, the helix is fully extended, as shown in the following figure. Since the lead
design allows for a versatile fixation site, it may be necessary to reposition the fluoroscopy camera or to advance the lead body in
order to see the entire helix.

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Figure 13. Extension and retraction of the helix
1. Helix fully extended
2. Helix fully retracted
3. Marker ring
4. Electrically active helix
Once fixation is verified, loosen the proximal thumbscrew on the fixation tool and carefully withdraw the stylet under fluoroscopic
observation. The lead tip should remain in position. Exercise caution during stylet retraction to avoid dislodging the lead.
Retraction of the J-shaped stylet may be more difficult than retraction of a straight stylet. A recommended method for retracting a J-
shaped stylet is to loosen the proximal thumbscrew and hold the stylet handle manually; then gently advance the lead body into the
atrium while simultaneously, but more slowly, advancing the stylet. Advance about twice as much lead as stylet; in this way, the J
shape widens and the stylet can be more readily removed.
Intraoperative Measurements
During implantation, the stimulation threshold and the intracardiac signal should be measured using a pacing system analyzer
(PSA). A low threshold value and high intracardiac signals are signs that the lead has been positioned satisfactorily.
WARNING
A pacing lead inserted into the heart presents a direct, low-impedance pathway for current flow to the myocardium.
Use only battery-powered test equipment for electrical measurements.
Connection to Pacing System Analyzer
Make sure that the percutaneous lead introducer and stylet are removed from the lead and that the lead is fixated in what is believed
to be a suitable location.
For more information, refer to the PSA manual.
CAUTION

Carefully apply alligator clips to the lead's connector pin to avoid damaging the insulation between terminals.

Do not use an alligator clip as an indifferent electrode by connecting it directly to tissue. This can result in
tissue trauma and cause inaccurate voltage thresholds and impedance measurements.
Recommended Values
Table 3. Recommended values on implantation, measured with a PSA
Measurement
Ventricle
Atrium
Maximum stimulation threshold value 0.5 V (1 mA) 1.0 V (2 mA)
Minimum intracardiac amplitude 5 mV 2 mV
Lead impedance 500–2000 ¬500–2000 ¬
If the initial measurements are different from those recommended above, it is best to wait a while and then repeat the
measurements. If the values do not stabilize at an acceptable level it may be necessary to alter the position of the electrode tip.
Secure the Lead
A suture sleeve is used to secure the lead to the vein or underlying fascia and to prevent damage to the insulation of the conductor
which otherwise might be caused by the ligature.
When the positioning and measurements are complete, firmly secure the lead with the suture sleeve to prevent the lead from sliding
along the vein and rotating.
The ligature around the sleeve should be tight enough to hold the lead still, but not so tight as to damage the insulation or the
conductor.
Sew the suture sleeve to the tissue. 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 14).

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Figure 14. Suturing the lead
1. Vein
2. Fascia
3. Lead body
CAUTION

Do not slide suture sleeve over the electrode ring.

Suture sleeve sticking can occur. If this occurs, carefully twist the sleeve off the ring toward the connector pin;
pulling the suture sleeve when it is positioned over the electrode ring may cause a tear in the lead body near the
electrode ring.

Do not apply the ligature directly to the lead body, as this can damage the lead’s insulation or conductor coil.

Do not tie the suture around the suture sleeve and lead too tightly, as this may result in excessive stress applied
to the lead body.

Use the suture sleeve to distribute the tension created by the suture. Failure to use the suture sleeve may result
in damage to the lead’s insulation or conductor coil.
Connection to the Device
Once the lead is anchored, connect the lead to the device following the instructions in the device manual.
Grasp the lead connector as close as possible to the connector pin while inserting the lead connector straight into the device port. If
necessary, regrip the lead and continue to insert the lead connector until it is fully seated in the device port.
CAUTION
Orient the excess lead length and the device to minimize the potential for insulation damage resulting from lead-to-
lead or device-to-lead interaction. For example, minimize the potential for leads lying on top of each other under
the device and ensure that there are no sharp bends in the lead. Lead insulation damage can create 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.3 4
CAUTION
Do not allow lead to become twisted. Instead, after connecting the lead, roll up surplus lead by rotating the device.
Place the loops that this makes under the device.
Lead Extraction
Infection of the implantable device system, particularly sepsis, may require the removal of both the device and the lead. Multiple
abandoned leads and limitations to venous access are other common reasons to recommend lead extraction.
If it is necessary to abandon an indwelling pacing lead, cap its connector pin. Never cut an indwelling pacing lead. Cutting an
indwelling pacing lead may cause the insulation to separate from the conductor coil and leave an exposed wire in the body.
If a lead must be removed due to infection or other serious reason, exercise great care, as lead extraction carries with it clinical risk.
Note
A pacing lead explanted for any reason should never be implanted in another patient.
It is generally recommended that a chronically implanted endocardial pacing lead not be repositioned except in special
circumstances.
Explantation
If the lead or any portion of it is extracted, handle it according to local regulations. Clean the explanted device with disinfectant and
return it to St. Jude Medical for investigation and safe disposal. For safety reasons, we recommend that all used leads be enclosed in
a protective cover.
3Furman S, Hayes DL, Holmes DR. A Practice of Cardiac Pacing. 3rd ed. New York: Futura Publishing, Inc.; 1993:286-289.
4Belott, 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; 1995:613-615.

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Please complete an Out of Service/Explant/Patient Death form and return it to St. Jude Medical with the explanted device. Whenever
possible, send along a printout of the programmed settings of the device.
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.
Specifications
Nominal Specifications
Length
46, 52, 58 cm
Connector Type
IS-1 bipolar
Maximum lead body size
7.9 French
Lead body tubing diameter
6.6 French
Fixation mechanism
Helix
Electrode configuration
Tip Active helix
Ring Cylindrical
Electrode surface area
Tip 6.0 mm2
Rings 16.5 mm2
Electrode length
Tip (extended) 1.8 mm
Tip to ring spacing
10 mm
Electrical resistance
Tip to connector pin 46 cm: 20 ¬52 cm: 22 ¬58 cm: 24 ¬
Ring to connector ring 46 cm: 46 ¬52 cm: 52 ¬58 cm: 59 ¬
Materials
Conductors Multifilar MP35N5
Connector Stainless steel
Lead body Optim™ insulation
Tip and ring electrodes Titanium nitride-coated platinum-iridium alloy
Soft tip Silicone rubber
Lead tip header PEEK, titanium
Steroid-eluting plug Silicone rubber with less than 1.0 mg dexamethasone sodium phosphate
MR Conditional markers Platinum
Suture sleeve Silicone rubber
Stylet Stainless steel
Typical number of rotations to extend helix for initial placement67
Straight stylet 6-10
J-stylet 8-11
Accessories
Table 4. Accessories
Lead cap
5MP35N is a trademark of SPS Technologies.
6Lead length, stylet configuration, and differences in anatomy may cause variations in the number of rotations required to extend the helix.
7Not to exceed 20 rotations.

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Table 4. Accessories
Vein pick
Suture sleeve
Stylet Kit with Clip-On Tool
Stylet Kit with Fixation Tool
Locator™ Plus Deflectable Stylet
Stylet Color Codes
Table 5. Stylet color codes
Knob Color
Description
Diameter
Green Soft straight (20 mm taper) 0.014 in/0.35 mm
Light green Extra-soft straight (40 mm taper) 0.014 in/0.35 mm
Green, white dot Soft (20 mm taper) 0.014 in/0.35 mm
Symbols
Symbols
The following symbols are used on the product or product packaging:
Table 6. Symbols
Symbol
Description
Authorized EC Representative in the European Community
Sterilized using ethylene oxide
Consult instructions for use
Follow instructions for use on this website
Date of Manufacture
Manufacturer
Country of manufacture; BE- Belgium, MY- Malaysia, US- United States
Do not reuse
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.
Device has been demonstrated to pose no known hazards in a specified MRI environment with
specified conditions of use.

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MR environment and conditions specified for MR Conditional use:
•Magnet strength: 1.5 Tesla
•Scan regions: Whole body
•SAR (specific absorption rate) ¢4 W/kg
For a complete set of conditions and environments, see the MRI Procedure Information
document.

Cardiac Rhythm Management Division
Manufacturer:
St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
[phone]
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
[phone]
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
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
July 2014
Art 60040859/A