Medtronic 5071-35 Technical Manual

5071

Sutureless, unipolar, myocardial, screw-in pacing lead

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or
on the order of a physician.

The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.

CareLink, Medtronic, Medtronic CareLink

Contents

1 Description/Intended Use 3
2 Contraindications 3
3 Warnings and precautions 4
4 Summary of clinical performance of the Model 5071

lead 5
5 Potential complications 9
6 Implant procedure 10
7 Specifications (nominal) 16
8 Medtronic warranty 18
9 Service 18

1 Description/Intended Use

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in
lead is designed for ventricular pacing and sensing. The lead has
application where permanent ventricular or dual-chamber pacing
systems are indicated. Two leads may be used for bipolar pacing.

The lead’s screw-in electrode is designed to be secured to the
myocardium with two clockwise turns. A polyester mesh allows fibrous
ingrowth for additional fixation.

The lead requires no stab wounds or sutures for electrode placement
and fixation. Tissue damage from electrode insertion may be
compared to the insertion of a 15-gauge needle.

The lead also features a MP35N nickel alloy conductor, silicone rubber
insulation and a unipolar connector (IS-1 UNI).

1.1 Package contents

1

Leads and accessories are supplied sterile. Each package contains
the following items:

●

1 lead

●

1 lead handle

●

1 tunneler

●

1 lead end cap

●

product literature

2 Contraindications

The lead should not be used on a patient with a thin-walled, heavily
infarcted, or fibrotic myocardium. It is also contraindicated for the
patient whose myocardium is suffused with fat.

1

IS-1 UNI refers to an International Connector Standard (ISO 5841-3) whereby pulse
generators and leads so designated are assured of a basic mechanical fit.

3

3 Warnings and precautions

Line-powered and battery-powered equipment – An implanted

lead forms a direct current path to the myocardium. During lead implant
and testing, use only battery-powered equipment or line-powered
equipment specifically designed for this purpose to protect against
fibrillation that may be caused by alternating currents. Line-powered
equipment used in the vicinity of the patient must be properly
grounded. Lead connector pins must be insulated from any leakage
currents that may arise from line-powered equipment.

Diathermy treatment (including therapeutic ultrasound) –

Diathermy is a treatment that involves the therapeutic heating of body
tissues. Diathermy treatments include high frequency, short wave,
microwave, and therapeutic ultrasound. Except for therapeutic
ultrasound, do not use diathermy treatments on cardiac device
patients. Diathermy treatments may result in serious injury or
permanent damage to an implanted device and leads. Therapeutic
ultrasound (including physiotherapy, high intensity therapeutic
ultrasound, and high intensity focused ultrasound), is the use of
ultrasound at higher energies than diagnostic ultrasound to bring heat
or agitation into the body. Therapeutic ultrasound is acceptable if
treatment is performed with a minimum separation distance of 15 cm
(6 in) between the applicator and the implanted device and leads, as
long as the ultrasonic beam is pointing away from the device and leads.

Magnetic resonance imaging (MRI) – An MRI is a type of medical
imaging that uses magnetic fields to create an internal view of the body.
Do not conduct MRI scans on patients who have this device or lead
implanted. MRI scans may result in serious injury, induction of
tachyarrhythmias, or implanted system malfunction or damage.

Single use – The lead and accessories are for single use only.

Inspecting the sterile package – Inspect the sterile package with

care before opening it.

●

Contact a Medtronic representative if the seal or package is
damaged.

●

Do not store this product above 40 °C (104 °F).

●

Do not use the product after its expiration date.

Sterilization – Medtronic has sterilized the package contents with
ethylene oxide before shipment. This lead is for single use only and is
not intended to be resterilized.

Handling a screw-in lead – Handle the lead with care at all times.

●

Do not implant the lead if it is damaged. Return the lead to a
Medtronic representative.

●

Protect the lead from materials that shed small particles such as lint
and dust. Lead insulators attract these particles.

●

Handle the lead with sterile surgical gloves that have been rinsed in
sterile water or a comparable substance.

●

Do not severely bend, kink, or stretch the lead.

●

Dry the electrode head and handle before remounting if the lead is
removed during surgery.

●

Do not immerse the lead in mineral oil, silicone oil, or any other
liquid, except blood, at the time of implant.

●

Do not use surgical instruments to grasp the lead.

4

●

Form a loop immediately behind the electrode to ensure proper
stability on the handle.

●

Do not force the lead if resistance is encountered during lead
passage.

Necessary hospital equipment – Keep external defibrillation
equipment nearby for immediate use during acute lead system testing,
the implant procedure, or whenever arrhythmias are possible or
intentionally induced during post-implant testing.

Concurrent devices – Output pulses, especially from unipolar
devices, may adversely affect device sensing capabilities. If a patient
requires a separate stimulation device, either permanent or temporary,
allow enough space between the leads of the separate systems to
avoid interference in the sensing capabilities of the devices. Previously
implanted pulse generators and implantable cardioverter defibrillators
should generally be explanted.

Chronic repositioning or removal of a screw-in lead – Chronic
repositioning or removal of the lead after it has been implanted in the
patient is not recommended. If removal is unavoidable, return the lead
to Medtronic.

If a lead is abandoned, it should be capped to avoid transmitting
electrical signals from the pin to the heart. A lead that has been cut off
should have the remaining lead end sealed and it should be sutured to
adjacent tissue to avoid migration.

4 Summary of clinical performance of the Model 5071 lead

4.1 Clinical study

The Medtronic Model 5071 lead is studied within the Medtronic System
Longevity Study (SLS). The SLS is a prospective, non-randomized,
multi-center study of implanted commercially available cardiac therapy
products. This study is currently being conducted in the United States
(US), Canada, and EMEA (Europe, Middle East and Africa).

As of the January 31, 2013 cutoff date, a total of 290 Model 5071 leads
in 212 subjects have been enrolled in the Medtronic System Longevity
Study (SLS). The first 5071 implant occurred on February 17, 1994.
There have been 21(in 17 subjects) reported Model 5071 lead-related
complications, and a total of 146 exits (including 37 deaths). The
observed survival rate of freedom from Model 5071 lead-related
complications at 5 years was 85.4%, with a 2-sided 95% confidence
interval of (76.8%, 91.1%).

4.2 Clinical inclusion and exclusion criteria

Subjects who meet the following inclusion criteria and do not meet any
of the following exclusion criteria are eligible for enrollment as subjects
in the SLS.

4.2.1 Inclusion criteria

●

Subjects or appropriate legal guardians provide written informed
consent and/or authorization for access to and use of health
information, as required by an institution’s IRB/MEC/REB.

AND one of the following (a or b) must also apply:

5

a. Subjects indicated for implant or within six months post-implant of a
Medtronic market-released lead connected to a market-released IPG,
ICD, or CRT Device. The Medtronic lead must be used for a pacing,
sensing or defibrillation application.

b. Subjects who participated in a qualifying study of a Medtronic
cardiac therapy product and for whom:

●

product is market-released

●

complete implant and follow-up data, including product-related
adverse events, are available

●

subject or appropriate legal guardian authorizes release of subject
study data to SLS

4.2.2 Exclusion criteria

●

Subjects receiving an implant of a Medtronic lead at a
non-participating center and the implant data and current status
cannot be confirmed within 30 days after implant

●

Subjects who are, or will be inaccessible for follow-up at a SLS
center

●

Subjects implanted with a Medtronic cardiac therapy device whose
predetermined enrollment limit for that specific product has been
exceeded

●

Subjects with exclusion criteria required by local law (Europe,
Middle East and Africa)

Data included in this clinical Safety and Efficacy Summary is a subset
of the SLS dataset. The subset criteria are:

●

A subject who is implanted with at least 1 Model 5071 lead with
valid implant date and product serial number

●

A subject is enrolled in a verifiable study center

4.3 Clinical study results

As of the cut-off date, 212 subjects have been enrolled in the study with
a Model 5071 lead, 91 (42.9%) subjects are female and 121 (57.1%)
are male. The average age was 53.4 years with 32 (15.1%) subjects
younger than 19 and 94 (44.3%) subjects older than 65 years of age.

4.3.1 Lead survival probability

As of the data cut-off date, 21 Model 5071 lead related complications
were observed in 21 Model 5071 leads. The survival curve is presented
in Figure 1. All enrolled Model 5071 leads were included in this
analysis. Subjects who exited the study due to a non-model 5071 lead
related reason were censored at the date of study exit. The observed
survival rate of freedom from Model 5071 lead-related complications at
5 years was 85.4%, with a 2-sided 95% confidence interval of (76.8%,

91.1%).

6

Figure 1. Kaplan-Meier Estimate of Model 5701 Complication Free

0%

0 6 12 18 24 30 36 42 48 54 60 66

277 190 145 124 102 88 77 65 62 58 48

43

50%

55%

60%

65%

70%

75%

80%

85%

90%

95%

100%

Months after Implant

Subjects at Risk

Complication-free Survival Rate

96.3%

95.2%

85.4%

Survival Probability

4.3.2 Adverse effects that occurred in the clinical study

As of the data cut-off date, there have been 21 (in 21 implanted Model
5071 lead, in 17 subjects) reported Model 5071 lead related chronic
complications. Table 1 is a summary of Model 5071 related
complications (or failure modes).

Table 1. Summary of complication rates

Number of

Complication

Abnormal impe-

jects)

1(1) 0.003 (0.0001, 0.0191)

dance

leads (in # sub-

Elevated Thresh-

3 (2) 0.010 (0.0021, 0.0299)

olds

Failure to

12 (10) 0.041 (0.0216, 0.0712)

Capture

Oversensing 2(1) 0.007 (0.0008, 0.0247)

Undersensing 1(1) 0.003 (0.0001, 0.0191)

a

Other

2(2) 0.007 (0.0008, 0.0247)

Overall 21(17) 0.072 (0.0454, 0.1086)

a

The cause of two lead revisions was not reported. These two events were
conservatively counted as lead related complications.

b

2-sided 95% Confidence Intervals are calculated using the Exact binomial
method.

4.3.3 Subgroup analyses

Additional ad-hoc analyses were carried out to further present Model
5071 lead safety performance in different age, gender and geographic
groups. It was observed that Model 5071 leads implanted in patients in
the age group of 19-65 years experienced better complication free
survival (93.9% at 5 years), comparing to either younger or older
patient group (75.5% and 79.0% at 5 years, respectively).

Complication

rate (N=290)

95% Confi-

dence interval

7

b

4.4 Effectiveness analysis

The study of Model 5071 lead within the System Longevity Study
Protocol did not intensively examine the efficacy performance of the
lead, i.e. there were no specific requirements regarding lead electrical
testing done at each follow-up visit. Model 5071 lead efficacy
performance data are summarized based on data collected from
(de-identified) patients who are implanted with Model 5071 leads and
Medtronic generators, and are registered in the Medtronic CareLink
remote monitoring system.

The effectiveness analysis was conducted utilizing device data
(n=3794) collected via Medtronic CareLink system. The Model 5071
lead observed mean LV pacing thresholds (weekly max) of 2.39±1.05V
at implant and 2.33 ± 0.98V at 5 years. The electrical performance was
stable over time and was within expected values, with 23.9-35.1% > 3V
through 5 years post implant.

4.5 Summary of supplemental clinical information

Most of the studied Model 5071 leads were enrolled in the SLS after
their successful implant procedure. Therefore, the clinical study does
not provide sufficient data to provide an unbiased evaluation of implant
tools, implant success rates and implanter experiences. Nonetheless,
Model 5071 leads were researched and published in several peer
reviewed Journals.

Implanting technique and experience for cardiac epicardial leads,
including Model 5071 leads, was discussed in the Mair2 paper which
was published in The Heart Surgery Forum (2003). The paper studied
three epicardial lead implantation techniques: (1) left lateral
mini-thoracotomy; (2) a video-assisted thoracoscopy approach using
lead implantation tools; and (3) a robotically enhanced
telemanipulation system. In a total of 80 patients, the study observed
that intended lead location on the LV was achieved in all patients. Acute
and 3-month LV lead thresholds were satisfactory in 79 patients (99%).
The paper detailed the thoracoscopic approach using the Medtronic
10626 epicardial lead implant tool for the Medtronic 5071 epicardial
pacing lead and concluded that the thoracoscopic approaches with
further improvements in the leads and implantation devices were at
least equivalent or possibly better treatment options than the coronary
sinus approach for BiV pacing.

2

Helmut Mair, Jean-Luc Jansens, Omar M. Lattouf, Bruno Reichart, Epicardial Lead
Implantation Techniques for Biventricular Pacing via Left Lateral Mini-Thoracotomy,
Video-Assisted Thoracoscopy, and Robotic Approach, The Heart Surgery Forum
Volume 6 (5), 2003

8

Screw-in epicardial lead implant techniques were also discussed in the
Navia3 paper published in The Annuals of Thoracic Surgery (2005).
This study enrolled patients for undergoing surgical epicardial
implantation after transvenous implantation failure. Surgical approach
was either endoscopic (video-assisted thoracoscopic surgery or
robotic) or by means of minithoracotomy. The paper compared safety
and efficacy of these two approaches and concluded that both
procedures were safe, with short procedure times, no implant failure,
no mortality, and minimal morbidity. Heart failure conditions were
improved in most patients.

Doll4 reported 7 cases of Model 5071 implant procedure using
Medtronic Model 10626 epicardial lead placement tool in The Annals
of Thoracic Surgery (2003). In 5 patients, the procedure was performed
at the same time as biventricular defibrillator implantation. Two patients
underwent isolated epicardial lead placement 1 day and 10 days after
failed transvenous LV lead placement. The paper concluded that the
implanting tool was safe and efficient.

Lead placement technique and CRT response after Model 5071 lead
implantation were studied in the Edgerton5 paper published in The
Annals of Thoracic Surgery (2007). A total of 29 patients with heart
failure class III or IV and had failed transvenous LV lead placement were
included in this study. All patients were prepared for thoracoscopic
placement of a Medtronic 5071 lead. A follow-up telephone survey was
carried out to measure change in the patients’ quality of life. The Model
5071 lead placements were 100% successful. The study reported that
Quality of Life scores improved in 90.9% of patients with mapped lead
placement and in 66.6% of the patients without mapped lead
placement.

In summary, this peer-reviewed clinical evidence demonstrates that
Model 5071 implanting tools are acceptable and that the implanting
technique is mature. Patient clinical outcome after receiving a Model
5071 lead is acceptable.

5 Potential complications

The potential complications related to the use of myocardial leads
include, but are not limited to, the following patient-related conditions
that can occur when the lead is being inserted or repositioned:

●

cardiac tamponade

●

fibrillation and other arrhythmias

●

heart wall damage

●

infection

●

muscle or nerve stimulation

●

pericardial rub

3

Navia Jose L, Fernando A, Grimm Richard, et. al. Minimally Invasive Left Ventricular
Epicardial Lead Placement: Surgical Techniques for Heart Failure
Resynchronization Therapy, The Annals of The Thoracic Surgery 2005;
79:1536-1544

4

Nicolas Doll, Ulrich T, et. al. Facilitated Minimally Invasive left Ventricular Epicardial
Lead Placement, The Annals of Thoracic Surgery 2005;79:1023–5

5

James R Edgerton, Zachary Edgerton, et. al. Ventricular Epicardial Lead
Placement for Resynchronization by Determination of Paced Depolarization
Intervals: Technique and Rationale, The Annals of Thoracic Surgery 2007;
83:89-92

9

Other potential complications related to the screw-in lead and the
programmed parameters include, but are not limited to, the
complications listed in the following table.

Complication Symptom

Cardiac strangulation Chest pain, general fati-

Lead dislodgement Intermittent or continu-

Lead conductor or helix
fracture or insulation
failure

Threshold elevation or

a

exit block

Bipolar pacing indica­ted (use two leads)

a

Transient loss of capture or sensing may occur for a short time following
surgery until lead stabilization takes place. If stabilization does not occur, lead
dislodgement may be suspected.

gue, syncope, symp­toms of myocardial
infarction, heart failure,
new cardiac murmur.

ous loss of capture or

a

sensing

Intermittent or continu­ous loss of capture or

a

sensing

Loss of capture

Increased risk of induc­ing tachyarrhythmia due
to equal surface area or
anodal and cathodal
electrodes

a

Corrective action to
be considered

Reposition or replace
the lead.

Reposition the lead.

Replace the lead.

Adjust the implantable
device output. Replace
or reposition the lead.

If the paced stimuli are
observed to be falling
on the T-Wave, it may
help to unipolarize the
system.

The potential complications listed above may occur at a higher rate with
the use of these leads in pediatric patients.

6 Implant procedure

Proper surgical procedures and sterile techniques are the
responsibility of the medical professional. Some implant techniques
vary according to physician preference and the patient’s anatomy or
physical condition.

6.1 Surgical approaches

A variety of surgical approaches can be used to implant this lead,
including limited thoracotomy, subxiphoid, transxiphoid, and
transmediastinal. In many cases, local anesthesia can be used.

6.2 Mounting the lead

Before implant, ensure that the lead is properly mounted on the handle.
If it is necessary to remount the lead, follow the instructions hereafter.

1. Insert the electrode head in the groove at the handle’s tip
(Figure 2). Insert the pointed tip of the tunneler into the handle
cavity. Slide it through the cavity until the tunneler’s slight
projections are in line with the notches on the handle. Then, rotate
the tunneler counterclockwise and pull it back until the projections
rest snugly within the two notches (Figure 3).

10

Figure 2. Electrode head in the groove of the handle

Figure 3. Fitting tunneler in the handle

2. Insert the lead body into the handle grooves while leaving a small
loop near the electrode head (Figure 4).

Figure 4. Loop near the electrode head

11

6.3 Lead fixation

The implant site should be an avascular area free of infarcts, fat, or
fibrosis. If bipolar pacing is indicated, a separate electrode may be
installed adjacent to the first with a minimum of 2.5 cm (0.98 in) space
between them (unless a different spacing is required for a particular
pulse generator).

To fixate the lead:

1. Place the mounted electrode tip in the desired position. Affix the
electrode to the myocardium with two clockwise turns. Each turn
is to be made during systole. Use only light pressure (Figure 5).

Figure 5. Affixing the lead

6

2. Electrical measurements should be taken before unloading the
lead from the handle. Initial electrical measurements may be
unsatisfactory because of acute cellular trauma. If this occurs,
wait five to ten minutes and repeat measurement procedures. If
electrical measurements remain unacceptable, another
implantation site should be selected.

3. Release the electrode and lead body by gripping the handle
between two fingers and gently pushing the tunneler in a
syringe-type action (Figure 6).

6

Refer to the Potential complications section of this manual.

12

Figure 6. Releasing the electrode and lead body

Caution: Heavy pressure on the electrode may force the

electrode through the myocardial wall. Make sure the electrode is
completely detached from the handle before removing the handle
from the operative site.

4. If a separate pocket is created for the pulse generator, the lead
should be passed within muscle layers to the pocket while
avoiding sharp angle bends of the lead body. Attach the lead
connector pin to the tunneler and pass the tunneler to the pocket
incision. When removing the lead from the tunneler, hold the lead
connector tightly near the pin and gently pull and twist off.

6.4 Acute lead repositioning

If lead repositioning is necessary and the lead has not been detached
from the handle, rotate the lead and handle assembly
counterclockwise two turns to achieve safe, acute lead removal.
However, if the lead has been detached from the handle, follow the
procedure below:

1. Remove the tunneler from the handle.

2. Carefully fit the handle’s curved groove over the electrode head.

3. Rotate the electrode head counterclockwise two to three turns to
achieve removal.

6.5 Taking electrical measurements

Low stimulation thresholds and adequate sensing of intra-cardiac
signal amplitudes indicate satisfactory lead placement. Medtronic
recommends using a voltage source such as a pacing system analyzer
for obtaining electrical measurements.

A low stimulation threshold provides for a desirable safety margin,
allowing for a possible rise in thresholds that may occur within two
months following implantation.

13

Adequate sensing amplitudes ensure that the lead is properly sensing
intrinsic cardiac signals. Minimum signal requirements depend on the
pulse generator’s sensitivity capabilities. Acceptable acute sensing
amplitudes for the lead must be greater than the minimum pulse
generator sensing capabilities including an adequate safety margin to
account for lead maturity.

Table 2. Recommended measurements at implant when using a pacing system analyzer

Measurement required

Maximum acute stimulation thresholds

Minimum acute sensing amplitudes 4.0 mV

a

At pulse duration setting of 0.5 ms.

a

1.0 V

These measurements assume a 500 Ω pacing resistance.

Initial electrical measurements may deviate from the
recommendations because of acute cellular trauma. If this occurs, wait
five to fifteen minutes and repeat the testing procedure.

Values may vary depending upon lead type, pulse generator settings,
cardiac tissue condition, and drug interactions.

If electrical measurements do not stabilize to acceptable levels, it may
be necessary to reposition the lead and to repeat the testing procedure.

For more information on obtaining electrical measurements, consult
the technical manual supplied with the testing device.

6.6 Connecting the lead

Connect the lead to the pulse generator according to the instructions in
the pulse generator manual.

The connector on the Model 5071 is a unipolar connector (IS-1 UNI).

IS-1 UNI and IS-1 Bl leads always have the label identification “IS-1
UNI” or “IS-1 Bl” on the connector. IS-1 UNI leads may sometimes be
further identified by a blue ring located distal to the connector pin.

1. Obtain final electrical measurements.

2. Insert the lead connector into the connector block on the device.
For instructions on proper lead connections, see the product
literature supplied with the device.

6.7 Placing the device and lead into the pocket

Cautions:

●

Use care when placing the device and lead into the pocket.

●

Ensure that the lead does not leave the device at an acute angle.

●

Do not grip the lead or device with surgical instruments.

●

Do not coil the lead (Figure 7). Coiling the lead can twist the lead
body and may result in lead dislodgment.

14

Figure 7. Do not coil the lead body

Caution: To prevent undesirable twisting of the lead body, wrap the

excess lead length loosely under the device and place both the device
and the lead into the subcutaneous pocket.

Place the device and lead into the pocket:

1. Rotate the device to loosely wrap the excess lead length under the
device (Figure 8).
Caution: Cardiac strangulation is a known rare complication of
myocardial lead placement. Signs and symptoms reported to be
associated with strangulation can include, but are not limited to,
chest pain, general fatigue, syncope, symptoms of myocardial
infarction, heart failure, and new cardiac murmur. Particular
attention should be taken for the appropriate placement and
routing of the lead to the pacemaker in order to reduce the risk of
cardiac strangulation.

Figure 8. While rotating the pulse generator, loosely wrap the excess lead length and place it under the pulse generator

2. Insert the device and lead into the pocket.

3. Suture the pocket closed.

4. Monitor the patient’s electrocardiogram until the patient is
discharged. If a lead dislodges, it usually occurs during the
immediate postoperative period.

6.8 Using the lead end cap

Use a lead end cap to seal off the connector pin (Figure 9) if the lead is
being reserved for pulse generator connection at a future date or if the
lead has been abandoned (i.e. any leads not explanted, but not
connected to the pulse generator).

Insert the end cap over the lead connector pin so that the sealing rings
on the lead are fully covered. Sterile water may be used to facilitate this
application. No adhesives are necessary. Tie a nonabsorbable,
synthetic ligature in the end cap’s groove.

15

Figure 9. Using the lead end cap

Caution: Do not secure the ligature so tightly that it damages the end

cap and the lead.

The end cap can be removed at a later date without damaging the lead.

7 Specifications (nominal)

Parameter Model 5071

Type Unipolar

Chamber Ventricle

Fixation Screw-in

Length 15–110 cm (5.9–43.3 in)

Connector IS-1 UNI

Material Conductor: MP35N

Connector pin: Stainless steel

Insulator: Treated silicone rubber

Helix electrode: Platinum alloy

Diameter Lead body: 2.2 mm (0.09 in)

Electrode surface
area

Helix length (fully extended) 3.5 mm (0.14 in) (2 turns)

Unipolar resistance 39 Ω (35 cm) (13.78 in)

Helix: 6.6 mm2 (0.26 in2)

59 Ω (53 cm) (20.87 in)

16

Figure 10. Model 5071 lead components

1 Electrode surface area: 6.6 mm2 (0.26 in2)
2 Electrode head
3 Connector pin diameter: 1.6 mm (0.06 in)
4 Lead body diameter: 2.2 mm (0.09 in)
5 Lead length:15–110 cm (5.9–43.3 in)

17

8 Medtronic warranty

For complete warranty information, see the accompanying warranty
document.

9 Service

Medtronic employs highly trained representatives and engineers
located throughout the world to serve you and, upon request, to provide
training to qualified hospital personnel in the use of Medtronic
products. Medtronic also maintains a professional staff to provide
technical consultation to product users. For more information, contact
your local Medtronic representative, or call or write Medtronic at the
appropriate telephone number or address listed on the back cover.

18

Medtronic, Inc.

*M953969A001*

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Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour
technical consultation for
physicians and medical
professionals)
Bradycardia: [phone]
Tachycardia: [phone]

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2015-04-30