Medtronic 5038-65 Technical Manual

CAPSURE® VDD-2 5038

Steroid eluting, implantable, tined, bipolar atrial sensing, bipolar ventricular sensing, and pacing 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, Medtronic, Thera

Contents

1 Description 3
2 Indications 4
3 Contraindications 4
4 Warnings and precautions 4
5 Potential complications 5
6 Adverse events 5
7 Clinical trials summary 6
8 Directions for use 7

9 Detailed device description 10
10 Service 12
11 Medtronic warranty 12

1 Description

The Medtronic CapSure VDD-2 Model 5038 steroid eluting,
implantable, tined, bipolar atrial sensing, bipolar ventricular
sensing and pacing, transvenous lead is designed for bipolar
sensing in the atrium, and bipolar sensing and pacing in the
ventricle. The CapSure VDD-2 Model 5038 lead is intended for
use with current Medtronic VDD pulse generators.

The lead has two ring electrodes for bipolar sensing in the atrium
and a ring electrode and a tip electrode for bipolar sensing and
pacing in the ventricle. All electrodes are composed of platinum
alloy and the tip electrode features a hemispherical microporous
surface composed of platinum that has been coated with steroid
dexamethasone sodium phosphate.

The tip electrode contains a maximum of 1.0 mg of
dexamethasone sodium phosphate, a portion of which is in a
silicone rubber binder. 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 lower threshold provided by the
steroid may permit reduced amplitude and pulse width settings in
programmable pulse generators thereby increasing pacemaker
longevity.

The lead also features four silicone tines near the electrode tip,
nickel-alloy conductor coils and treated silicone outer insulation.

The lead comes with a bipolar ventricular connector, indicated by
an embedded IS-1 BI VEN label, and a bipolar atrial connector,
indicated with an ATRIAL SENSE label. The bipolar ventricular
connector is an IS-11 bipolar (BI) connector. The ATRIAL SENSE

connector is a bipolar connector which meets the mechanical and
functional requirements of the IS-1 standard, but is only designed
for sensing functions.

The connector pin of the ventricular connector is electrically
connected to the ventricular electrode tip, and the connector ring
of the ventricular connector is electrically connected to the
ventricular electrode ring. The connector pin of the atrial
connector is electrically connected to the distal atrial electrode
ring, and the connector ring of the atrial connector is electrically
connected to the proximal atrial electrode ring.

Only the ventricular connector allows the use of a stylet wire.

The following standard combinations of lead length and A-V
spacing are available:

Spacing between
ventricular tip and

Lead model Lead length

5038S-52 52 cm 115 mm

5038-58 58 cm 135 mm

5038S-58 58 cm 115 mm

5038L-65 65 cm 155 mm

5038-65 65 cm 135 mm

center of atrial ring
pair

The Model 5038-58, lead with 58 cm lead length and 135 mm
spacing; and the Model 5038-65 lead, with 65 cm lead length and
135 mm spacing, should be appropriate for the majority of patients
with average heart sizes. An X-ray of the patient’s heart may be
useful in estimating the heart size and determining whether the
length for the tip electrode to the midpoint of the atrial rings is
appropriate. The Model 5038S-58 with 58 cm lead and 115 mm
spacing and the Model 5038L-65, with 65 cm lead length and
155 mm spacing, may be useful for patients with unusually small
or large hearts.

Note: Special care must be taken when prescribing this system for
pediatric patients by assuring that the A-V spacing is appropriate
for the heart size, that the atrial rings are placed within the atrium,
and that adequate P-wave values are obtained.

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

1

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

3

2 Indications

The Model 5038 lead is designed to be used with Medtronic VDD
pulse generators as part of a cardiac pacing system. The lead has
application where implantable atrial sensing and ventricular
pacing and sensing dual chamber pacing systems are indicated.

3 Contraindications

When tricuspid valvular disease is present, use of a ventricular
transvenous lead is contraindicated.

The use of endocardial ventricular leads are contraindicated in
patients with mechanical tricuspid heart valves.

Do not use steroid eluting leads in patients for whom a single dose
of 1.0 mg dexamethasone sodium phosphate may be
contraindicated.

4 Warnings and precautions

Sterilization – Medtronic has sterilized the package contents

with ethylene oxide before shipment. This device is for single use
only and is not intended to be resterilized.

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

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.

Necessary hospital equipment – Defibrillating equipment
should be kept nearby for immediate use during the implantation
procedure.

Inspecting the package – Inspect the lead sterile package prior
to opening. If the seal or package is damaged, contact your local
Medtronic representative.

If the container, the sterile package, or the lead appear to have
been damaged do not use the lead. Contact your Medtronic
representative and return the damaged lead.

Before inserting the lead – Use an anchoring sleeve with all
leads. Ensure that the anchoring sleeve is positioned close to the
lead’s bifurcation sleeve at the connector side. This will prevent
inadvertent passage of the sleeve into the vein.

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

Leads should be handled with great care at all times. Any severe
bending, kinking, stretching, handling with surgical instruments or
excessive force when inserting a stylet may cause permanent
damage to the lead. If the lead is damaged, do not implant. Return
the lead to your Medtronic representative.

Lead insulators attract small particles such as lint and dust.
Therefore, to minimize contamination, protect the lead from
materials shedding these substances. Handle the lead with sterile
surgical gloves that have been rinsed in sterile water or equivalent.

Do not immerse leads in mineral oil, silicone oil or any other liquid.

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

Do not allow the electrode surface to come in contact with surface
contaminants. Do not wipe or immerse the electrode in fluid. Such
treatment of a steroid eluting lead will reduce the amount of steroid
available when the lead is implanted and may adversely affect
low-threshold performance.

Chronic repositioning – Chronic repositioning or removal of
tined leads may be difficult because of fibrotic tissue
development. Chronic removal can result in avulsion of the
endocardium, valve or vein. In addition, the lead conjunctions may
separate, leaving the lead tip and bare wire in the heart or vein. In
most clinical situations, it is preferable to abandon unused leads in
place.

However, if a lead must be removed or repositioned, proceed with
extreme caution. If a lead is removed, inspect it carefully for
insulator or conductor coil damage. (Medtronic requests all
removed or unused leads or portions thereof be returned for
analysis.) 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 into the
heart.

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

4

See additional cautions in the section titled “Directions for
use.”

5 Potential complications

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:

●

air embolism

●

cardiac perforation

●

cardiac tamponade

●

fibrillation and other arrhythmias

●

heart wall rupture

●

infection

●

muscle or nerve stimulation

●

pericardial rub

●

pneumothorax

●

valve damage (particularly in fragile hearts, e.g. infants)

●

venous thrombosis leading to stenosis or emboli

Other potential complications related to the lead and the
programmed parameters include, but are not limited to, the
following:

Complication Symptom

Lead dislodgement Intermittent or contin-

uous loss of ventricu­lar capture or sens­inga, atrial sensing,
false A-V triggering

Lead conductor frac­ture or insulation fail­ure

intermittent or contin­uous loss of ventricu­lar capture or sens­inga, or atrial sensing,
or atrial and ventricu­lar oversensing

Threshold elevation
or exit block

a

Transient loss of capture or sensing may occur for a short time following

Loss of ventricular

a

capture

surgery until lead stabilization takes place. If stabilization does not occur,
lead dislodgement may be suspected.

Potential procedural complications during lead placement
include, but are not limited to, the following:

Corrective action to
be considered

Reposition the lead.

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.

Adjust the pulse gen­erator output.
Replace or reposition
the lead.

Procedural compli­cation Problem

Forcing the lead
through the introducer

Electrode, tines fixa­tion, or insulation

Corrective action to
be considered

Replace the lead

damage

Binding of the lead
between the clavicle
and first rib

Potential conductor
coil fracture, insula­tion compression

Replace the lead

fracture, polyurethane
degradation

Periosteum and/or
tendon puncture

Advancing withdraw
stylet into lead simul­taneously with lead
advancement

Conductor coil frac­ture

Tip distortion and per­foration

Replace the lead

Keep the stylet fully
inserted until the lead
is advanced into the
heart

6 Adverse events

6.1 Adverse events

The clinical investigation of the Medtronic Thera VDD/CapSure
VDD2 system involved 178 systems implanted in 178 patients for
a total of 2100 cumulative device months of experience (mean =

11.8 months). Thirteen patients died during the course of the
clinical study. None of the deaths were judged to be related to the
device. Adverse events (AEs), including 9 complications and 29
observations, were reported during the clinical investigation. The
following table reports these data on a per patient and a per
patient-month basis.

# of

Type of AE

patients

(n=178)

% of

patients

Observationsa(29)

Angina 1 0.56% 1 .0005 2100

Atrial Over-

1 0.56% 1 .0005 2100

sensing

Atrial Under-

16 8.99% 16 .0076 131

sensing

Dizziness 3 1.69% 3 .0014 700

Elevated

2 1.12% 2 .0010 1050
Pacing
Thresholds

Fatigue 2 1.12% 2 .0010 1050

Palpitations 2 1.12% 2 .0010 1050

Pain/Swel-

2 1.12% 2 .0010 1050
ling at
Pocket Site

Complicationsb (9)

AE

#

s

AE/Pt-M

O

(n=210

0)

Pt Mos

Between

AEs

2

This data was obtained with the Medtronic Model 5032 CapSure VDD lead in a clinical study which concluded in February 1995. Clinical studies were not performed
on the Model 5038 CapSure VDD-2 lead due to its similarity in design and function to the Model 5032 lead. The clinical data collected for the Model 5032 lead therefore
supports the safety and efficacy claims for the Model 5038 lead and is included here for reference purposes. The Model 5038 lead differs from the Model 5032 lead
in the following minor ways: downsized bifurcation area, smaller introducer size (9 French without guidewire; with guidewire, 12 French), increased stylet socket depth.

5

# of

Type of AE

Lead reposi­tioned

Pulse gener­ator reposi­tioned

Reprogram­med to
VVI/R due to
loss of atrial
sensing

a

Observations are adverse events which are correctable by noninvasive
measures, e.g., reprogramming.

b

Complications are adverse events requiring invasive measures to correct
(e.g., surgical intervention, programming out of VDD mode) or the loss of
a significant function of the device.

patients

(n=178)

6 3.40% 6 .0029 350

1 0.56% 1 .0005 2100

2 1.12% 2 .0010 1050

% of

patients

AE

#

s

AE/Pt-M

O

(n=210

0)

Pt Mos

Between

AEs

Other possible side effects include, but are not limited to, body
rejection phenomena including local tissue reaction, fibrotic
tissue formation, muscle and nerve stimulation, infection, erosion
of pacemaker lead through skin, myopotential sensing,
transvenous lead-related thrombosis, embolism, and cardiac
tamponade. Also, see the section Chapter 5.

7 Clinical trials summary

7.1 Conclusion

The Medtronic Thera VDD/CapSure VDD pacing system3 was
proven to be safe and effective. VDD mode retention rate was

98.8% (excluding patients who were reprogrammed to VVI/R due
to changing sinus condition). With the enhanced 0.18 mV
capability, VDD mode retention rate is 99.4%. These results
suggest that the Thera VDD system provides stable and reliable
chronic atrial sensing performance.

7.1.1 Primary objectives

Primary Objective One: Demonstrate the safety of the Thera
VDD/CapSure VDD pacing system.

Primary Objective Two: Demonstrate effective atrial sensing and
tracking provided by the Thera VDD/CapSure VDD pacing
system.

7.1.2 Methods

Prior to study enrollment, all patients were screened for adequate
sinus node competence by exercise testing, hall walk, ECG or
Holter monitoring. Patients where randomly assigned to either the
Thera VDD/CapSure VDD system or a two-lead control system in
a 1:1 ratio.

Controls were implanted with new, standard atrial and ventricular
leads. Active or passive fixation leads were allowed in the atrium.
Bipolar, passive fixation, steroid eluting leads (e.g., Medtronic
Model 5024 or Medtronic 4024) were required in the ventricle.

7.1.3 Results

Forty-three centers worldwide are participating in an ongoing
clinical study to evaluate atrial sensing performance with the
Medtronic single-lead VDD system (Thera VDD/CapSure VDD).
One hundred seventy-eight patients have been implanted with the
VDD system, representing 2100 device-months of experience.
Mean follow-up (FU) time is 11.8 months. Mean age is 67.3 ± 14.8;
range 10–87 years. Typical indications are 2° or 3° AV block with
normal sinus node function.

Related to Primary Objective One, there were no unanticipated
Adverse Device Events and the device related complication
survival was not statistically different from that of the Control (P=

0.6035).

Related to Primary Objective Two, there were no postoperative
CapSure VDD lead explants or cap/abandonments. Six leads
were repositioned. 156 patients continue to be followed in the
study (9 lost-to-follow-up and 13 patient deaths, none related to
the pacing system or implantation). Mean minimum P-wave
thresholds remained stable over time: 1.0 mV at 1 month, 1.1 mV
at 3 months, 1.1 mV at 6 months and 1.1 mV at one year. Percent
of synchronization was calculated from Event Counter data at the
6 month FU. More than half of the patients had 100% AS-VP (see
Figure 1). Temporary P-wave undersensing was resolved for
several patients at pre-discharge by adjusting sensitivity. Two
patients were reprogrammed to VVIR due to loss of atrial sensing,
but since the more sensitive 0.18 mV setting has become
available, one has regained VDD mode. Twelve patients
developed atrial arrhythmias (2 brady and 10 tachy) of which 3
were reprogrammed to VVI/R and the other 9 remained in VDD
with or without Mode Switching ON.

Note: The ability to consistently sense P-waves with the VDD
system is dependent upon proper lead positioning, with the atrial
bipole in close proximity to the atrial wall. In the Thera VDD
controlled clinical trial, the observed rate of programming out of
VDD mode due to loss of atrial sensing was 1.1% higher in the
VDD group compared to the standard two-lead DDD group.

3

This data was obtained with the Medtronic Model 5032 CapSure VDD lead in a clinical study which concluded in February 1995. Clinical studies were not performed
on the Model 5038 CapSure VDD-2 lead due to its similarity in design and function to the Model 5032 lead. The clinical data collected for the Model 5032 lead therefore
supports the safety and efficacy claims for the Model 5038 lead and is included here for reference purposes. The Model 5038 lead differs from the Model 5032 lead
in the following minor ways: downsized bifurcation area, smaller introducer size (9 French without guidewire; with guidewire, 12 French), increased stylet socket depth.

6

Figure 1. Percent of synchronization (AS-VP) at 6 months FU

0

25

50

75

100

Percent of AS-VP

Percent of patients

(cumulative)

n=126

100%

>98%

>95%

>90%

>80%

1

8 Directions for use

The implantation procedure generally includes using a stylet
guide, stylets, and vein lifter; selecting an insertion site;
positioning the lead; and connecting the lead to the pulse
generator.

Some implantation techniques vary according to physician
preference and the patient’s anatomy or physical condition. As
described below, the techniques for selecting an insertion site,
using a stylet guide or a stylet, positioning a lead, and anchoring a
lead suggest one or two possible versions, while more may exist.

8.1 Using a stylet guide and stylets

The lead is packaged with the stylet guide attached to the
connector pin and a stylet already inserted. If the stylet guide has
been removed, replace it by gently pushing it as far as possible
onto the connector pin of the ventricular connector leg (see
Figure 2), which is indicated with an IS-1 BI VEN label.

Caution: A stylet can only be introduced via the ventricular
connector pin.

Figure 2.

A stylet provides additional stiffness and controlled flexibility for
maneuvering the lead into position. Stylets vary in diameter and
length to accommodate a physician’s preference.

Insert a stylet wire through the stylet guide. If a slight curve is
needed for the stylet, refer to the instructions in the section titled
“Lead Positioning in the Right Ventricle.”

Caution: To avoid damage to the lead or body tissue, do not use
excessive force or surgical instruments to insert a stylet into the
lead. To avoid lead tip distortion, the stylet should always remain
fully inserted into the lead during lead introduction and while
advancing the lead, especially through tortuous veins that may
cause the stylet to “back out” of the lead. When handling a stylet,

avoid overbending, kinking or blood contact. If blood is allowed to
accumulate on a stylet, passage of the stylet into the lead may be
difficult.

8.2 Selecting an insertion site

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. Select the desired entry site (see
Figure 3).

Caution: When using a subclavian approach, avoid placing the
entry site in a location where the lead body can be clamped
between the clavicle and the first rib. A more lateral approach is
recommended to avoid first rib clavicular crush. Clamping of the
lead may eventually cause the conductor to fracture and may
cause other damage to the lead. Certain anatomical
abnormalities, such as thoracic outlet syndrome, may also
precipitate clamping of the lead.

Use fluoroscopy to facilitate accurate lead placement.

Figure 3. Suggested point of insertion

1 Suggested entry site

8.3 Using the vein lifter

A vein lifter facilitates lead introduction. Insert its tapered end into
the incised vein and gently push the lead tip underneath and into
the vein (see Figure 4).

Caution: Avoid placing the lead under extreme tension or
angualtion to prevent lead dislodgement and possible lead
fracture. Avoid gripping the lead with surgical instruments.

Figure 4. Using the vein lifter

7

8.4 Lead positioning in the right ventricle

Advance the lead into the right atrium. For added control in
maneuvering the lead tip through the tricuspid valve, the distal end
of the lead may be slightly curved by inserting a gently curved
stylet (see Figure 5). The lead tip may then be advanced directly
through the valve, or it can be projected against the lateral atrial
wall and the curved portion of the lead backed across the tricuspid
valve.

Figure 5. Imparting a curve to the stylet with a smooth object

Caution: To avoid damange to the stylet, do not use a sharp

object to impart a curve to the distal end.

Due in part to the tines and the flexible nature of the lead, difficulty
may be encountered when passing the lead through the tricuspid
valve or its chordae tendineae. One way to minimize difficulty is to
rotate the stylet or lead about on its axis as it is advanced or
withdrawn through the valve.

After the lead tip is passed into the right ventricle, the curved stylet
may be replaced with a straight stylet. To avoid using excessive tip
force while achieving final electrode position, withdraw the stylet
slightly or back the distal lead tip out of the pulmonary outflow
tract. To minimize the occurrence of perforation, avoid known
infarcted or thin ventricular wall areas.

Accurate positioning and wedging of the electrode tip are
essential for stable endocaridal pacing of the right ventricle. A
satisfacotry position is achieved when the lead tip points straight
toward the apex or when the dispal end dips or bends slightly (see
Figure 6).

Figure 6. Typical placement of the tined lead near the ventricular apex (A-P view).

After positioning and wedging the ventricular electrode tip, place
the atrial electrode ring pair in close proximity to the myocardium.
Base the optimum position on the P-wave amplitude
measurements where either the most consistent P-wave
amplitudes or the largest minimum P-wave are attained during
deep breathing. This position may be verified by fluoroscopy.

Care should be taken to avoid placement in the proximity of the
A-V valve or of the inflow tract of the vena cava. The system is
completed with connection of this lead to a specific type of pulse
generator which provides the necessary high atrial sensitivity (up
to 0.25 mV level).

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

8.5 Taking electrical measurements

A notch in the stylet guide allows connection of a surgical cable on
the ventricular connector pin for electrical measurements (see
Figure 7).

Figure 7. Surgical cable connection

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

Small P-wave amplitudes may be confused with other electrical
signals, like far-field QRS complexes. This may result in false
readings. Therefore, Medtronic advises the recording of the
intra-atrial EGM to verify the correctness of the pacing system
analyzer readings.

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

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 signal amplitudes for the lead must be greater
than the minimum pulse generator sensing capabilities including
an adequate safety margin to account for lead maturity.
Recommended values are listed in the next table.

8

Before taking final measurements, carefully remove the stylet and

1

stylet guide completely. When removing the stylet guide, grip the
lead firmly just below the connector pin; this will help prevent
possible lead tip dislodgement.

Table 1. Recommended electrical measurements at implant when using a pacing system analyzer

Measurement required

Maximum acute stimulation
thresholds

Minimum acute sensing ampli­tudes

a

At pulse duration setting of 0.5 ms.

b

Take the minimum P-Wave during deep inspiration.

a

Ventri­cle Atrium

1.0 V

3.0 mA——

5.0 mV 1.0 mV

b

Initial ventricular 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 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.

8.6 Pacing impedance for ventricular electrode

Ventricular pacing impedance (or resistance) is used to assess
pulse generator function and lead integrity during routine pulse
generator patient follow-up 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 significantly affected by measurement
technique; therefore, 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: pacing
artifact size and morphology changes in 12-lead analog ECGs,
muscle stimulation with bipolar leads, sensing and/or capture
problems, patient symptoms, and pulse generator characteristics.

Medtronic has developed the following recommendations for
clinically monitoring and evaluating leads in terms of impedance
characteristics.

For pulse generators with telemetry readout of impedance:

●

Routinely monitor and record impedance values at implant
and follow-ups. All current Medtronic VDD pulse generators
provide impedance values using consistent output settings
(note, impedance values may be different at different

programmable output settings [e.g. pulse width or pulse
amplitude] of the pulse generator or pacing system analyzer).

●

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

●

The Medtronic VDD pulse generator will automatically report
lead impedance values which fall outside of the established
range (see the technical manual delivered with the Medtronic
VDD pulse generator for more information).

●

Where impedance abnormalities occur, closely monitor the
patient for indications of pacing and sensing problems.

●

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

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

8.7 Anchoring the lead

Use the slotted triple groove anchoring sleeve to secure the lead
from moving and to protect the lead insulation and conductor coil
from damage caused by tight ligatures.

Anchor the lead with nonabsorbable sutures.

Caution: Tabs on anchoring sleeves are provided to minimize the
possibility of the sleeve entering the vein. Do not remove the tabs
(see Figure 8 ). 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 and/or venous
system.

Figure 8. Slotted triple groove anchoring sleeve with tabs

1 Anchoring sleeve tab

With a slotted triple groove anchoring sleeve, generally two or
three of the grooves may be used with the following procedure
(see Figure 9 and Figure 10).

The slotted triple groove anchoring sleeve is situated at the
connector end of the lead. Partially insert the anchoring sleeve
into the vein.

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

Use the middle groove to secure the anchoring sleeve to the fascia
and lead. First, create a base by looping a suture through the
fascia underneath the middle groove and tying a knot. Continue by
firmly wrapping the suture around the middle groove and tying a
second knot.

9

Figure 9. Slotted triple groove anchoring sleeve secured to the lead and fascia using three grooves.

Use the third and most proximal groove to secure the anchoring
sleeve to the lead body.

Alternatively, the physician may decide to use only two of the three
grooves on the anchoring sleeve to tie down the lead. In that case,
follow the anchoring procedure for the distal and middle groove
(see Figure 10).

Caution: Do not use the anchoring sleeve tabs for suturing.

Figure 10. Slotted triple groove anchoring sleeve secured to the

lead and fascia using two grooves.

Tie the sutures securely but gently to prevent damage to the
slotted triple groove anchoring sleeve.

Caution: Do not secure the ligatures so tightly that they damage
the vein or lead. Do not tie a ligature directly to the lead body (see
Figure 11). During anchoring, take care to avoid dislodging the
lead tip.

Figure 11. Do not secure the sutures too tightly and do not tie a suture to the lead body.

named IS-1 since the atrial electrode ring pair is only designed for
sensing and not for pacing, as required by the IS-1 standard to
allow IS-1 identification.

Caution: The Medtronic CapSure VDD-2 Model 5038 is intended
for use with current Medtronic VDD pulse generators.

Caution: Always remove the stylet before connecting the lead to
the pulse generator. Failure to remove the stylet may result in lead
failure.

Caution: To prevent undesirable twisting of the lead body, wrap
the excess lead length loosely under the pulse generator and
place both into the subcutaneous pocket (see Figure 12).

Figure 12. While rotating the pulse generator, loosely wrap the excess lead length and place it under the pulse generator

Caution: When placing the pulse generator and leads into the
subcutaneous pocket:

●

Do not coil the lead. Coiling the lead can twist the lead body
and may result in lead dislodgement (see Figure 13).

●

Do not grip the lead or pulse generator with surgical
instruments.

After implantation, monitor the patient’s electrocardiogram
continuously. If a lead dislodges, it usually occurs during the
immediate postoperative period.

Figure 13. Do not coil the lead body

8.8 Connecting the lead to the pulse generator

Connect the ventricular IS-1 Bipolar (BI) lead connector, identified
by the IS-1 BI VEN label, and the atrial bipolar connector,
identified by the ATRIAL SENSE label, to the pulse generator,
according to the instructions in the pulse generator manual.

Note: The bipolar atrial connector meets the mechanical and
functional requirements of the IS-1 standard, but cannot be

10

9 Detailed device description

Table 2. Specifications (nominal)

Parameter Model 5038

Type Quadripolar

Chamber Dual (atrial sense and ventricu-

lar pace and sense)

Table 2. Specifications (nominal) (continued)

Parameter Model 5038

Fixation 4 tines, each 3.0 mm in length

Length 58 cm or 65 cm (5038)

58 cm or 52 cm (5038S)

65 cm (5038L)

Connectors Ventricular: IS-1 BI

Atrial: Bipolar

Material Conductor: MP35N

Insulator: Treated silicone rubber

Ring electrode: Platinum alloy

Tip electrode: Platinum alloy

Tines: Silicone rubber

Tip electrode configuration Hemispherical, platinized,

Diameters Lead body: 2.65 mm

Atrial ring section

body:

Ventricular tip elec-

trode:

Ventricular ring

electrode:

Atrial ring electro-

des:

Lead introducer (recommended size)

without guide wire: 3.0 mm (9 French)

with guide wire: 4.0 mm (12 French)

Electrode sur-

Ventricular tip: 5.8 mm

face area

Ventricular ring: 36.0 mm

Atrial rings: 12.5 mm2 (each)

Resistance Unipolar ventricu-

lar:

Bipolar ventricular: 98 Ω (58 cm)

Bipolar atrial : 743 Ω (58 cm)

Distance
between elec-

Ventricular tip and

ventricular ring:

trodes

Ventricular tip and

center of atrial ring

pair:

Atrial rings: 8.6 mm

Steroid Dexamethasone sodium phos-

Amount of steroid <1.0 mg

Steroid binder Silicone rubber

a

The Atrial sense connector meets the mechanical and functional
requirements of the IS-1 standard (ISO 5841-3), but is only designed for
sensing functions.

b

See Chapter 1 for a listing of available lead models, including lead length
and V-A spacing.

a

porous, steroid eluting

3.00 mm

1.70 mm

2.85 mm

3.00 mm

2

2

45 Ω (58 cm)

28 mm

b

135 mm

phate

Figure 14.

1 Tip electrode: 1.7 mm
2 Atrial ring pair to ventricular tip distance: 115 – 155 mm
3 Ventricular tip to ring spacing: 28 mm
4 Proximal ventricular ring electrode area: 36 mm
5 Distal ventricular tip electrode area: 5.8 mm
6 Atrial ring spacing: 8.6 mm
7 Proximal atrial ring electrode surface area: 12.5 mm
8 Distal atrial ring electrode surface area: 12.5 mm

2

2

2

2

11

9 Lead body: 2.65 mm
10 Lead length: 52 – 65 cm
11 Slotted
12 6.1 mm

10 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.

11 Medtronic warranty

For complete warranty information, see the accompanying
warranty document.

12

Medtronic, Inc.

*M955236A001*

710 Medtronic Parkway
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]

Europe/Middle East/Africa

Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
[phone]

Technical manuals

www.medtronic.com/manuals

© 2014 Medtronic, Inc.
M955236A001 A
2014-06-09