Medtronic 407385 Technical Manual

CAPSURE SENSE® 4073

Steroid-eluting, unipolar, implantable, tined, ventricular, transvenous 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.

CapSure, CapSure Sense, Medtronic

Contents

1 Description 3
2 Drug component description 3
3 Indications 3
4 Contraindications 3
5 Warnings and precautions 4
6 Drug information 5
7 Potential adverse events 5
8 Directions for use 6

9 Specifications 10
10 Medtronic warranty 11
11 Service 11

1.2 Accessory descriptions

Dispose of all single-use accessories according to local
environmental requirements.

Anchoring sleeve – An anchoring sleeve secures the lead to
prevent it from moving and protects the lead insulation and
conductors from damage caused by tight sutures.

Stylet – A stylet provides additional stiffness and controlled
flexibility for maneuvering the lead into position. Each stylet knob
is labeled with the stylet diameter and length.

Stylet guide – A stylet guide facilitates stylet insertion into the
lead.

Vein lifter – A vein lifter facilitates lead insertion into a vein.

2 Drug component description

1 Description

The Medtronic CapSure Sense Model 4073 steroid-eluting,
unipolar, implantable, tined, ventricular, transvenous lead is
designed for ventricular pacing. The platinum alloy tip electrode
features a high-active surface area of titanium nitride
microstructure. This electrode configuration contributes to low
polarization.

The tip electrode of the lead incorporates a steroid-eluting plug
containing dexamethasone acetate. The tip electrode contains a
target nominal dosage of 272 µg of dexamethasone. Upon
exposure to body fluids, the steroid elutes from the electrode.

The lead is designed to provide low chronic pacing thresholds via
steroid treatment of cardiac tissue near the lead tip. Steroid
suppresses the inflammatory response that is believed to cause
threshold rises typically associated with implanted pacing
electrodes.

The lead features four polyurethane tines near the electrode tip,
an MP35N nickel-alloy conductor, polyurethane insulation and an
IS-1 Unipolar (UNI)1 lead connector.

1.1 Package contents

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

●

1 lead with anchoring sleeve, stylet, and stylet guide

●

1 vein lifter

●

extra stylets

●

product documentation

The active ingredient in the Model 4073 lead is dexamethasone
acetate. Dexamethasone acetate is 9-Fluoro-11β,
17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
21-acetate. Dexamethasone acetate has a molecular formula of
C24H31FO6 and a molecular weight of 434.50. The MCRD
excipient is silicone. See Figure 1 for the structural formula.

Figure 1.

The target dosage of dexamethasone acetate is 272 µg per lead.

3 Indications

The Model 4073 implantable, ventricular, transvenous lead has
application where implantable ventricular, single-chamber or
dual-chamber pacing systems are indicated. The lead is intended
for pacing in the ventricle.

4 Contraindications

●

Use of ventricular transvenous leads is contraindicated in
patients with tricuspid valvular disease.

●

Use of ventricular transvenous leads is contraindicated in
patients with mechanical tricuspid heart valves.

●

Use of steroid eluting transvenous leads is contraindicated in
patients for whom a single dose of 272 µg dexamethasone
acetate may be contraindicated.

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

5 Warnings and precautions

Note: Medical procedure warnings and precautions that pertain

to the Medtronic implanted system are provided in the manual that
is packaged with the device or on the Medtronic Manual Library
website (www.Medtronic.com/manuals).

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 damage to an implanted device and leads.
Therapeutic 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.

Vessel and tissue damage – Use care when positioning the
lead. Avoid known infarcted or thin ventricular wall areas to
minimize the occurrence of perforation and dissection.

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

Inspecting the sterile package – Inspect the sterile package

with care before opening it.

●

If the seal or package is damaged, contact a Medtronic
representative.

●

Store at 25 °C (77 °F). Excursions from this storage
temperature are permitted in the range of 15 to 30 °C (59 to
86 °F). (See USP Controlled Room Temperature.) According
to USP excursion conditions, transient spikes up to 40 °C
(104 °F) are permitted as long as they do not exceed 24 hours.

●

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.

Steroid use – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone acetate apply to the use of this highly localized,
controlled-release lead. For a list of potential adverse effects,
refer to the Physicians’ Desk Reference.

Handling the steroid tip – Avoid reducing the amount of steroid
available before implanting the lead. Reducing the available

amount of steroid may adversely affect low-threshold
performance.

●

Do not allow the electrode surface to come in contact with
surface contaminants.

●

Do not wipe or immerse the electrode in fluid, except blood,
at the time of implant.

Handling a tined 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.

●

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.

●

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

Handling the stylet – Handle the stylet with care at all times.

●

Curve the stylet before inserting it into the lead to achieve a
curvature at the lead’s distal end. Do not use a sharp object
to impart a curve to the distal end of the stylet.

●

Do not use excessive force or surgical instruments when
inserting the stylet into the lead.

●

Avoid overbending or kinking the stylet.

●

Use a new stylet when blood or other fluids accumulate on
the stylet. Accumulated blood or other fluids may damage the
lead or cause difficulty in passing the stylet into the lead.

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.

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.

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 tined lead – Proceed
with extreme caution if a lead must be removed or repositioned.
Chronic repositioning or removal of tined transvenous leads may
be difficult because of fibrotic tissue development on the lead. In
most clinical situations, it is preferable to abandon unused leads

4

in place. Return all removed leads, unused leads, or lead sections
to Medtronic for analysis.

●

Lead removal may result in avulsion of the endocardium,
valve, or vein.

●

Lead junctions may separate, leaving the lead tip and bare
wire in the heart or vein.

●

Chronic repositioning of a lead may adversely affect a steroid
lead’s low-threshold performance.

●

An abandoned lead should be capped so that the lead does
not transmit electrical signals.

●

Severed leads should have the remaining lead end sealed
and the lead body sutured to adjacent tissue.

Connector compatibility – Although the lead conforms to the
IS-1 International Connector Standard, do not attempt to use the
lead with any device other than a commercially available
implantable pacing system with which it has been tested and
demonstrated to be safe and effective. The potential adverse
consequences of using such a combination may include, but are
not limited to, undersensing cardiac activity and failure to deliver
necessary therapy.

6 Drug information

6.1 Mechanism of action

Steroid suppresses the inflammatory response that is believed to
cause threshold rises typically associated with implanted pacing
electrodes. Dexamethasone acetate is a synthetic steroid of the
glucocorticoid family. Glucocorticoids have potent
anti-inflammatory actions via direct and indirect effects on major
inflammatory cells. Glucocorticosteroids bind to a cytoplasmic
glucocorticoid receptor as well as a membrane-bound receptor.
Binding to the cytoplasmic receptor leads to receptor activation
and translocation to the nucleus. The receptor interacts with
specific DNA sequences within the regulatory regions of affected
genes. Thus, glucocorticoids inhibit the production of multiple cell
factors that are critical in generating the inflammatory response.

6.2 Pharmacokinetics and metabolism

Pharmacokinetics – The pharmacokinetics (local drug levels

and systemic levels) of dexamethasone acetate and its
metabolites following implant were not evaluated in human
clinical trials. When delivered intra-muscularly, the lipid-soluble
dexamethasone acetate is slowly absorbed throughout the
tissue.

Metabolism – The conversion of dexamethasone acetate to
dexamethasone occurs within hours. The dexamethasone
alcohol (dexamethasone) is the active glucocorticoid used in this
Medtronic lead. Steroid is applied via MCRD (Monolithic
controlled release device) and eluted to the tissue interface where
it will be used. The form of the steroid, whether it is a prodrug or
the pharmacologically active dexamethasone, is irrelevant, as the
steroid is directly present at the injury site to treat the
inflammation. Dexamethasone acetate is hydrolyzed into
dexamethasone, which is readily absorbed by the surrounding

tissue and body fluids. Glucocorticoids, when given systemically,
are eliminated primarily by renal excretion of inactive metabolites.

6.3 Mutagenesis, carcinogenicity, and reproductive toxicity

Mutagenesis, carcinogenicity and reproductive toxicity –

The mutagenesis, carcinogenicity, and reproductive toxicity or
the Model 4073 lead have not been evaluated. However, the
mutagenesis, carcinogenicity, and reproductive toxicity of
dexamethasone acetate has been evaluated previously.

Carcinogenesis, mutagenesis, and impairment of fertility –

No adequate studies have been conducted in animals to
determine whether corticosteroids have a potential for
carcinogenesis (tumor initiation or promotion). Dexamethasone
was genotoxic in assays for clastogenicity (including sister
chromatid exchange in human lymphocytes) but not in an assay
for mutagenicity in salmonella (Ames test).

Adrenocorticoids have been reported to increase or decrease the
number and mobility of spermatozoa in some patients.

6.4 Pregnancy

Pregnancy – Dexamethasone acetate has been shown to be

teratogenic in many species when given in doses equivalent to
the human dose. There are no adequate and well-controlled
studies in pregnant women. Dexamethasone acetate should be
used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. Studies in mice, rats, and rabbits have
shown that adrenocorticoids increase the incidence of cleft
palate, placental insufficiency, and spontaneous abortions, and
can decrease the intrauterine growth rate.

Nursing mothers – Systemically administered corticosteroids
appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward
effects in nursing infants. Because of the potential for serious
adverse reactions in nursing infants from corticosteroids, a
decision should be made whether to discontinue nursing or to use
a non-steroidal lead, taking into account the importance of the
lead and the drug to the mother.

6.5 Lactation

Corticosteroids are secreted into human milk and there is a
potential for serious adverse reactions. A decision should be
made whether to nurse or to discontinue the drug, taking into
account the importance of the drug to the mother. These potential
risks of corticosteroids should also be considered along with any
other steroidal therapy being received by the patient.

7 Potential adverse events

The potential complications (listed in alphabetical order) related
to the use of transvenous leads include, but are not limited to, the
following patient-related conditions that can occur when the lead
is being inserted or repositioned:

●

cardiac perforation

●

cardiac tamponade

5

●

fibrillation and other arrhythmias

●

heart wall rupture

●

infection

●

muscle or nerve stimulation

●

pericardial rub

●

pneumothorax

●

thrombolytic and air embolism

●

thrombosis

●

valve damage (particularly in fragile hearts)

Other potential complications related to the tined lead and the
programmed parameters include, but are not limited to, the
complications listed in the following table. Symptoms of the
following potential complications include loss of capture or
intermittent or continuous loss of capture or sensing2:

Complication

Lead dislodgement Reposition the lead.

Lead conductor fracture or insula­tion failure

Threshold elevation or exit block Adjust the implantable device out-

Corrective action to be consid­ered

Replace the lead. In some cases
with a bipolar lead, the implantable
device may be programmed to a
unipolar configuration or the lead
may be unipolarized.

put. Replace or reposition the lead.

Potential acute or chronic complications associated with tined
lead placement that may require lead replacement to correct
include, but are not limited to, the following:

patient’s anatomy or physical condition. Each physician must
apply the information in these instructions according to
professional medical training and experience.

8.1 Opening the package

Within the sterile field, open the sterile package and remove the
lead and accessories.

8.2 Using a stylet guide and stylets

Caution: To avoid lead tip distortion, keep the stylet fully inserted

into the lead during lead introduction and while advancing the
lead. Keeping the stylet fully inserted into the lead is especially
important while navigating through tortuous veins that may cause
the stylet to “back out” of the lead.

Caution: To avoid damage to the stylet, do not use a sharp object
to impart a curve to the distal end of a stylet (Figure 2).

The lead is packaged with the stylet guide attached to the
connector pin and a stylet already inserted into the lead. If the
stylet guide has been removed, replace it by gently pushing it as
far as possible onto the connector pin (Figure 3).

Figure 2.

Implant technique Potential complication

Forcing the lead through the intro­ducer

Use of too medial of an approach
with venous introducer resulting in
clavicle and first rib binding

Puncturing the periosteum and/or
tendon when using subclavian
introducer approach

Advancing the lead into the
venous insertion site and/or
through the veins without the stylet
fully inserted

Electrode damage, tine damage,
insulation damage

Conductor coil fracture, insulation
damage

Conductor coil fracture, insulation
damage

Tip distortion, insulation perfora­tion

Use the stylet guide to insert a stylet into the lead. If a slight curve
is needed for the stylet, use only a smooth object to impart a curve
to the distal portion of a stylet (Figure 2).

Figure 3.

8 Directions for use

Proper surgical procedures and sterile techniques are the
responsibility of the medical professional. The following
procedures are provided for information only. Some implantation
techniques vary according to physician preference and the

2

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.

6

8.3 Selecting an insertion site

1

Caution: When using a subclavian approach, insert the lead

using a more lateral approach to minimize the risk of first rib
clavicular crush. First rib clavicular crush may subsequently
fracture the lead body.

Caution: Certain anatomical abnormalities, such as thoracic
outlet syndrome, may pinch and subsequently fracture the lead
body.

The lead may be inserted by venotomy through several different
venous routes, including the right or left cephalic vein, other
subclavian branches, or the external or internal jugular vein. The
lead may also be inserted into a subclavian vein through a
percutaneous lead introducer (PLI). Select the desired entry site
(Figure 4).

Note: If wiping the lead is necessary before insertion, ensure that
the anchoring sleeve remains in position.

Figure 4.

1 Suggested entry site

8.4 Using the vein lifter

1. Advance the lead into the right atrium.

2. Use fluoroscopy to facilitate accurate lead placement.

3. Rotate and pass the lead through the tricuspid valve.
Rotating the lead or stylet eases passage of the lead as it is
advanced through the tricuspid valve or its chordae
tendineae.
Note: For added control in maneuvering the lead tip through
the tricuspid valve, curve the distal end of the lead slightly by
inserting a gently curved stylet. Refer to Section 8.2 for
instructions about imparting a curve to a stylet. The lead tip
may then be directly advanced through the valve, or it may
be projected against the lateral atrial wall with the curved
portion of the lead backed across the tricuspid valve.

4. If using a curved stylet, replace the curved stylet with a
straight stylet after the lead tip is passed into the right
ventricle.

5. Withdraw the stylet slightly or back the distal lead tip out of
the pulmonary outflow tract to avoid using excessive tip force
while achieving the final electrode position.

6. Use fluoroscopy (lateral position) to ensure that the tip is not
in a retrograde position or is not lodged in the coronary sinus.

Accurate positioning and wedging of the electrode is essential for
stable pacing and sensing. A satisfactory position is achieved
when the lead tip points straight toward the apex or when the distal
end dips or bends slightly (Figure 6).

Figure 6.

Caution: Use care when handling the lead during insertion. Avoid

placing the lead under extreme tension or angulation to prevent
possible lead fracture. Avoid gripping the lead with surgical
instruments.

Use the vein lifter:

1. Insert the tapered end of the vein lifter into the incised vein
(Figure 5).

Figure 5.

2. Gently push the lead tip underneath the vein lifter and into
the vein.

8.5 Positioning a tined ventricular lead

Warning: To minimize the occurrence of perforation and

dissection, avoid known infarcted or thin ventricular wall areas.

Position a tined ventricular lead:

8.6 Taking electrical measurements

Take electrical measurements:

1. Attach the clip of a surgical cable to the notch on the stylet
guide (Figure 7).

Figure 7.

7

Note: A unipolar lead requires the use of an indifferent
electrode.

2. Use an implant support instrument to obtain electrical
measurements. Medtronic recommends using a pacing
system analyzer. For information on the use of the implant
support instrument, see the product literature for that device.
Satisfactory lead placement is indicated by low stimulation
thresholds and adequate sensing of intracardiac signal
amplitudes. Refer to Table 1 for recommended stimulation
threshold and sensing amplitude measurements at implant.

●

A low stimulation threshold provides for a desirable
safety margin, allowing for a possible rise in thresholds
that may occur within 2 months following implant.

●

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

Table 1. Recommended measurements at implant

Ventricle Atrium

Maximum acute stimulation thresholds

Minimum acute sensing amplitudes 5.0 mV 2.0 mV

a

At pulse duration setting of 0.5 ms.

a

1.0 V

3.0 mA

1.5 V

4.5 mA

3. If electrical measurements do not stabilize to acceptable
levels, repositioning the lead and repeating the testing
procedure may be necessary.
Note: Initial electrical measurements may deviate from the
recommendations because of acute cellular trauma. If such
a deviation occurs, wait 5 to 15 min and repeat the testing
procedure. Values may vary depending upon lead type,
device settings, cardiac tissue condition, and drug
interactions.

8.6.1 Checking diaphragmatic stimulation for tined leads

Diaphragmatic stimulation should also be checked by pacing at
10 V and a pulse width setting greater than 0.5 ms and observing
for diaphragmatic contracting either by fluoroscopy or direct
abdominal palpitation. This should be checked for both atrial and
ventricular leads. Further testing may include patient positional
changes to simulate upright chronic conditions.

If diaphragmatic pacing occurs, reduce the voltage until a
diaphragmatic pacing threshold is determined. A diaphragmatic
threshold of 5 to 6 V or less usually necessitates repositioning of
the lead.

8.6.2 Taking pacing impedance (or resistance) measurements

Pacing impedance (or resistance) is used to assess device
function and lead integrity during routine device patient follow-up
sessions and to assist in troubleshooting suspected lead failures.

Additional troubleshooting procedures include ECG analysis,
visual inspection, measurement of thresholds, and electrogram
characteristics.

Pacing impedance values are affected by many factors including
lead position, electrode size, conductor design and integrity,
insulation integrity, and the patient’s electrolyte balance.
Apparent pacing impedance is also significantly affected by the
measurement technique. Comparison of pacing impedance
should be done using consistent methods of measurements and
equipment.

An impedance higher or lower than the typical values is not
necessarily a conclusive indication of a lead failure. Other causes
must be considered as well. Before reaching a conclusive
diagnosis, the full clinical picture must be considered. The full
clinical picture includes pacing artifact size and morphology
changes in 12-lead analog ECGs, muscle stimulation with bipolar
leads, sensing and/or capture problems, patient symptoms, and
device characteristics.

Recommendations for clinically monitoring and evaluating leads
in terms of impedance characteristics are listed below.

Consider the following recommendations for devices with
telemetry readout of impedance:

●

Routinely monitor and record impedance values at implant
and follow-up sessions using consistent output settings.
Note: Impedance values may be different at different
programmable output settings (for example, pulse width or
pulse amplitude) of the device or pacing system analyzer.

●

Establish a baseline chronic impedance value once the
impedance has stabilized, generally within 6 to 12 months
after implant.

●

Monitor for significant impedance changes and abnormal
values.

●

Where impedance abnormalities occur, closely monitor the
patient for indications of pacing and sensing problems. The
output settings used for measuring impedance should be the
same as those used for the original measurements.

●

For patients at high risk, such as implantable
device-dependent patients, physicians may want to consider
further action such as increased frequency of monitoring,
provocative maneuvers, and ambulatory ECG monitoring.

Consider the following recommendations for devices without
telemetry:

●

Record the impedance value at implant. Also record the
measurement device, its output settings, and the procedure
used.

●

At the time of device replacement, if pacing system
analyzer-measured impedance is abnormal, carefully
evaluate lead integrity (including thresholds and physical
appearance) and patient condition before electing to reuse
the lead.

●

Impedances below 250 Ω may result in excessive battery
current drain, which may seriously compromise device
longevity, regardless of lead integrity.

8

For more information on obtaining electrical measurements,

1

consult the product literature supplied with the testing device.

8.7 Anchoring the lead

Cautions:

●

Use care when anchoring the lead.

●

Use an anchoring sleeve with all leads.

●

Do not use absorbable sutures to anchor the lead.

●

Do not secure the sutures so tightly that they damage the vein,
lead, or anchoring sleeve.

●

Do not use the anchoring sleeve tabs for suturing (Figure 8).

●

Do not tie a suture directly to the lead body (Figure 9).

●

Do not dislodge the lead tip.

●

Do not attempt to remove or cut the anchoring sleeve.

●

Do not remove the tabs on anchoring sleeves. Tabs are
provided to minimize the possibility of the sleeve entering the
vein.

●

If using a large diameter percutaneous lead introducer (PLI)
sheath, extreme care should be taken to prevent passage of
the anchoring sleeve into the PLI lumen or the venous system.

Figure 8.

1 Anchoring sleeve tab

Figure 9.

Figure 10.

5. If anchoring with all 3 grooves, use the most proximal groove
to secure the anchoring sleeve to the lead body (Figure 11).

Figure 11.

8.8 Connecting the lead

Caution: Always remove the stylet and stylet guide before

connecting the lead to the device. Failure to remove the stylet and
stylet guide may result in lead failure.

Connect the lead to the device:

1. Carefully and completely remove the stylet and stylet guide.
Note: When removing the stylet and stylet guide, firmly grip
the lead just below the connector pin to help prevent possible
lead dislodgement.

2. Obtain final electrical measurements.

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

8.9 Placing the device and lead into the pocket

With a triple groove anchoring sleeve, generally 2 or 3 of the
grooves may be used with the following procedure.

Anchor the lead:

1. Position the anchoring sleeve close to the lead’s connector
pin to prevent inadvertent passage of the sleeve into the vein.

2. Insert the anchoring sleeve partially into the vein.

3. Use the most distal suture groove to secure the anchoring
sleeve to the vein.

4. Use the middle groove to secure the anchoring sleeve to the
fascia and lead (Figure 10):

a. Create a base by looping a suture through the fascia

underneath the middle groove and tying a knot.

b. Firmly wrap the suture around the middle groove and tie

a second knot.

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 12). Coiling the lead can twist the
lead body and may result in lead dislodgement.

Figure 12.

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.

9

Place the device and lead into the pocket:

1. Rotate the device to loosely wrap the excess lead length
under the device (Figure 13).

Figure 13.

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.

8.10 Post-implant evaluation

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

Recommendations for verifying proper lead positioning include
x-rays and pacing and sensing thresholds taken at pre-hospital
discharge, 3 months after implant, and every 6 months thereafter.

In the event of a patient death, explant all implanted leads and
devices and return them to Medtronic with a completed Product
Information Report form. Call the appropriate phone number on
the back cover if there are any questions on product handling
procedures.

Parameter Model 4073

Tip electrode: 1.6 mm

Lead introducer (recommended size)

without guide wire: 2.3 mm (7 French)

with guide wire: 2.6 mm (8 French)

Electrode
surface area

Resistance 40 Ω (58 cm)

Steroid Dexamethasone acetate

Amount of steroid 272 µg (target dosage)

Steroid binder Silicone

Tip 2.5 mm

2

9 Specifications

Parameter Model 4073

Type Unipolar

Chamber Ventricle

Fixation 4 tines, each 2.5 mm in length

Lengths 20-110 cm

Connector IS-1 UNI

Material Conductor: MP35N nickel alloy

Connector pin: Stainless steel

Connector ring: Stainless steel

Insulator: Polyurethane

Tip electrode: Titanium nitride coated platinum

Tip electrode configuration Ring-shaped, porous, titanium

Diameters Lead body: 1.2 mm

10

alloy

Tines: Polyurethane

nitride coated, steroid-eluting

Figure 14.

10 Medtronic warranty

For complete warranty information, see the accompanying
warranty document.

11 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.

1 Lead length: 20-110 cm
2 Tip electrode; surface area: 2.5 mm
3 Insulation material: polyurethane
4 Connector: IS-1 UNI

2

11

World Headquarters

*M954534A001*

Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. [phone]
Fax [phone]

Medtronic USA, Inc.

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

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.com
Tel. [phone]
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Medtronic E.C. Authorized Representative

Medtronic B.V.
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The Netherlands
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Technical manuals:
www.medtronic.com/manuals

© Medtronic, Inc. 2013
M954534A001A
2013-02-17