Medtronic 5086MRI45 Technical Manual

CAPSUREFIX MRI™ SURESCAN™ 5086MRI

Steroid-eluting, bipolar, implantable, screw-in, ventricular/atrial, 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.

CapSureFix, CapSureFix MRI, Medtronic, Quick Twist, SureScan

Contents

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

9 Device description 12
10 Medtronic warranty 13
11 Service 13

1 Description

The Medtronic CapSureFix MRI SureScan Model 5086MRI
steroid-eluting, bipolar, implantable, screw-in, ventricular/atrial,
transvenous lead is designed for pacing and sensing applications
in either the atrium or ventricle. The lead has been designed for
use in the MRI environment when used with a Medtronic
MRI SureScan IPG. The platinum alloy tip and ring electrodes
feature a high-active surface area of titanium nitride
microstructure. This electrode configuration contributes to low
polarization.

The lead has a helical tip electrode made of platinum alloy that can
be actively fixed in the endocardium. The helix electrode can be
extended or retracted by rotating the lead connector pin with either
the Quick Twist tool attached to the lead or with the white fixation
tool. An active fixation lead is particularly beneficial for patients
who have smooth or hypertrophic hearts where lead
dislodgement may be a potential problem. The lead also has a
second, larger electrode proximal to the helical tip electrode and
an IS-1 Bipolar (BI) connector1 with one terminal pin. It features
MP35N nickel alloy conductors and silicone rubber insulation.
The outer insulation of the lead has been treated to facilitate ease
of implant.

The distal tip contains a nominal dosage of 680 µg of
dexamethasone acetate. Upon exposure to body fluids, the
steroid elutes from the lead tip. The steroid is known to suppress
the inflammatory response that is believed to cause threshold
rises typically associated with implanted pacing electrodes.

The Medtronic SureScan pacing system includes a Medtronic
SureScan device connected to Medtronic SureScan leads.
Labeling for SureScan pacing system components displays the
SureScan symbol and the MR Conditional symbol.

SureScan logo

MR Conditional symbol. The Medtronic MRI SureScan pacing
system is MR Conditional and, as such, is designed to allow
implanted patients the ability to undergo an MRI scan under the
specified MRI conditions for use.

The MRI SureScan feature permits a mode of operation that
allows a patient with a SureScan device to be safely scanned by
an MRI machine while the device continues to provide appropriate
pacing. When programmed to On, MRI SureScan operation
disables arrhythmia detection, magnet mode, and all
user-defined diagnostics. Before performing an MRI scan,

refer to the SureScan pacing system technical manual for
important information about procedures and MRI-specific
warnings and precautions.

1.1 Package contents

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

●

1 lead with radiopaque anchoring sleeve, stylet, and Quick
Twist tool

●

1 white fixation tool

●

1 vein lifter

●

extra stylets

●

product documentation

1.2 Accessory descriptions

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.

White fixation tool – The white fixation tool facilitates connector
pin rotation.

Quick Twist tool – The Quick Twist tool facilitates both connector
pin rotation and stylet insertion into the lead. This tool comes
attached to the lead.

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.

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

2 Drug component description

The active ingredient in the Model 5086MRI 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
(Monolithic controlled release device) excipient is silicone. See
Figure 1 for the structural formula.

1

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

3

Figure 1.

The target dosage of dexamethasone acetate is 680 µg per lead.

3 Indications

The Medtronic MRI SureScan lead is indicated for use as a
system consisting of a Medtronic MRI SureScan IPG
implanted with SureScan leads. A complete system is
required for use in the MRI environmentThis lead has

application where implantable dual chamber MR Conditional
pacing systems are indicated.

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 680 µg dexamethasone
acetate may be contraindicated.

5 Warnings and precautions

Before performing an MRI scan, refer to the SureScan
pacing system technical manual for MRI-specific 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 lead system.
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 lead system, as long as the ultrasonic beam
is pointing away from the device and lead system.

Magnetic resonance imaging (MRI) – An MRI is a type of
medical imaging that uses magnetic fields to create an internal
view of the body. If certain criteria are met and the warnings and
precautions provided by Medtronic are followed, patients with an
MR Conditional device and lead system are able to undergo an
MRI scan; for details, refer to the MRI Technical Manual that
Medtronic provides for the MR Conditional device.

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 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.

4

●

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 or connector
pin.

●

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

●

Exercise the helix electrode before implanting the lead. On
initial extension, more rotations may be required to extend and
retract the helix electrode, or the helix electrode may extend
suddenly when torque is built up.
Note: The estimated number of rotations (using the fixation
tool) needed to initially extend or retract the helix electrode is
stated in Table 3.

●

Ensure helix is retracted prior to implant.

●

The number of turns required to extend and subsequently
retract the helix may be different. Verify helix electrode
extension and retraction using fluoroscopy during implant
(Figure 8). Overrotation of the connector pin may result in
fracture or distortion of the inner conductor or retraction of the
helix electrode out of its channel.

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.

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 lead removal and the SureScan pacing system –

When implanting a SureScan pacing system, consider the risks
associated with removing previously implanted leads before
doing so. Abandoned leads or previously implanted
non-SureScan labeled leads compromise the ability to safely
scan the SureScan pacing system during MRI scans.

Chronic repositioning or removal of a screw-in lead –

Proceed with extreme caution if a lead must be removed or
repositioned. Chronic repositioning or removal of screw-in
transvenous leads may not be possible because of blood or

fibrotic tissue development into the helix mechanism on the lead.
In most clinical situations, it is preferable to abandon unused leads
in place. Return all removed leads, unused leads, or lead sections
to Medtronic for analysis.

Note: If a helix electrode does not disengage from the
endocardium by rotating the connector pin, rotating the lead body
counterclockwise may withdraw the helix electrode and decrease
the possibility of damage to cardiovascular structures during
removal.

●

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 the
low-threshold performance of a steroid lead.

●

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 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

●

fibrillation and other arrhythmias

●

heart wall rupture

●

infection

●

muscle or nerve stimulation

●

myocardial irritability

●

pericardial rub

●

pericarditis

●

pneumothorax

●

thrombotic and air embolism

●

thrombosis

●

valve damage (particularly in fragile hearts)

5