Medtronic 6935M62 Technical Manual

SPRINT QUATTRO SECURE S MRI™ SURESCAN™ 6935M

MR Conditional, steroid-eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode

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.

AccuRead, Evera, Evera MRI, Medtronic, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Secure S, Sprint Quattro Secure S MRI, SureScan,
Tensi-Lock

Contents

1 Description 3
2 Drug component description 4
3 Indications 4
4 Contraindications 4
5 Warnings and precautions 4
6 Adverse events and clinical trial data 6
7 Drug information 6
8 Directions for use 7

9 Specifications (nominal) 13
10 Medtronic disclaimer of warranty 15
11 Service 15
12 Explanation of symbols on package labeling 15

1 Description

The Medtronic Sprint Quattro Secure S MRI SureScan Model
6935M lead is a steroid-eluting, tripolar, screw-in, ventricular lead
with a right ventricular (RV) defibrillation coil electrode. The lead is
designed for pacing, sensing, cardioversion, and defibrillation
therapies. The following lead lengths are MR conditional: 55 cm
and 62 cm. Other lead lengths are not MR conditional.

The lead features an extendable and retractable helix electrode,
silicone insulation, and parallel conductors. The 3 electrodes of
the lead are the helix, ring, and RV coil. The lead also features
Tensi-Lock1 and silicone-backfilled defibrillation coils.

The Medtronic DF4-LLHO2 four-pole HV inline connector on the
lead facilitates device connection during implant. The DF4
connector pin has a color band indicator that may be used to
visually confirm proper connection to the device.

The RV coil delivers cardioversion and defibrillation therapies.
Pacing and sensing occur between the helix and either the ring or
RV coil electrode. An AccuRead analyzer cable interface tool (ACI
tool) is attached to the lead to facilitate accurate electrical
measurements during implant.

The helix electrode can be actively fixed into the endocardium.
The helix electrode can be extended or retracted by rotating the
DF4 connector pin with the purple fixation tool included in the
package.

The distal tip contains a nominal dosage of 685 µg of
dexamethasone acetate and 59 µg of dexamethasone sodium
phosphate. Upon exposure to body fluids, the steroids elute from

the lead tip. The steroids are known to suppress the inflammatory
response that is believed to cause threshold rises typically
associated with implanted pacing electrodes.

1.1 Medtronic SureScan defibrillation system

A complete SureScan defibrillation system is required for
use in the MR environment. A complete SureScan
defibrillation system includes a Medtronic SureScan device
with the appropriate number of Medtronic SureScan leads.

The Model 6935M lead is part of the Medtronic SureScan
defibrillation system. Labeling for SureScan defibrillation system
components displays the MR Conditional symbol. To verify that
components are part of a SureScan system, visit
http://www.mrisurescan.com. Any other combination may result
in a hazard to the patient during an MRI scan.

The MRI SureScan feature permits a mode of operation that
allows a patient with a SureScan system 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 and all user-defined diagnostics.
Before performing an MRI scan, refer to the MRI Technical
Manual.

1.2 Package contents

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

●

1 lead with a radiopaque anchoring sleeve, stylet, and ACI tool

●

2 purple fixation tools

●

1 purple stylet guide

●

1 slit anchoring sleeve

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1 vein lifter

●

extra stylets

●

product literature

1.3 Accessory descriptions

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

AccuRead analyzer cable interface (ACI) tool – The ACI tool
facilitates accurate electrical measurements during implant and
prevents possible connector damage.

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.

Purple fixation tool – The purple fixation tool facilitates
connector pin rotation.

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

Slit anchoring sleeve – A slit anchoring sleeve secures excess
lead length in the device pocket.

1

Tensi-Lock is an exclusive Medtronic design feature that utilizes lead body cables to act like a built-in locking stylet and add tensile strength to the lead.

2

DF4-LLHO refers to the international standard ISO 27186:2010, where the lead connector contacts are defined as low voltage (L), high voltage (H), or open (O).

3

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 corresponding lead length.

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

2 Drug component description

The active ingredients in the Model 6935M lead are
dexamethasone acetate [21-(acetyloxy)-9-fluoro-11β,
17-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione] and
dexamethasone sodium phosphate [9-fluoro-11β,
17-dihydroxy-16α-methyl-21-(phosphonooxy)
pregna-1,4-diene-3,20-diene-3,20-dione disodium salt]. The
structural formula for these steroids is shown in the following
figures.

Dexamethasone acetate is a white to practically white, odorless
powder. It is a practically insoluble ester of dexamethasone, a
synthetic adrenocortical steroid.

Figure 1. Structural formula for dexamethasone acetate (DXAC)
C24H31FO

Dexamethasone sodium phosphate is an inorganic ester of
dexamethasone, a synthetic adrenocortical steroid.
Dexamethasone sodium phosphate is a white or slightly yellow
crystalline powder. It is freely soluble in water and is very
hygroscopic.

Figure 2. Structural formula for dexamethasone sodium
phosphate (DSP) C22H28FNa2O8P

The maximum dosage of dexamethasone acetate and
dexamethasone sodium phosphate is less than 1.0 mg per lead.

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3 Indications

The lead is intended for single, long-term use in the right ventricle.

This lead has application for patients for whom implantable
cardioverter defibrillators (ICDs) are indicated.

4 Contraindications

Atrial use – The lead is contraindicated for the sole use of

detection and treatment of atrial arrhythmias.

Ventricular use – The lead is contraindicated for ventricular use
in patients with tricuspid valvular disease or a tricuspid
mechanical heart valve.

Transient ventricular tachyarrhythmias – The lead is
contraindicated for patients with transient ventricular
tachyarrhythmias due to reversible causes (drug intoxication,
electrolyte imbalance, sepsis, hypoxia) or other factors
(myocardial infarction, electric shock).

Steroid use – The lead is contraindicated in patients for whom a
single dose of 1.0 mg of dexamethasone acetate and
dexamethasone sodium phosphate may be contraindicated.

5 Warnings and precautions

A complete SureScan defibrillation system is required for
use in the MR environment. Before performing an MRI scan,
refer to the MRI Technical Manual for MRI-specific warnings
and precautions.

Inspecting the sterile package – Inspect the sterile package

before opening it.

●

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

●

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

●

Do not use the product after its expiration date.

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

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.

Connector compatibility – Although the lead conforms to the
International Connector Standard for DF4, do not attempt to use
the lead with any device other than a commercially available
implantable defibrillator 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.

Electrophysiologic testing – Prior to lead implant, it is strongly
recommended that patients undergo a complete cardiac
evaluation, which should include electrophysiologic testing. Also,
electrophysiologic evaluation and testing of the safety and
efficacy of the proposed pacing, cardioversion, or defibrillation

4

therapies are recommended during and after the implant of the
system.

Steroid use – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone sodium phosphate or dexamethasone acetate
apply to the use of this highly localized, controlled-release device.
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 the lead – Handle the lead with care at all times.

●

Protect the lead from materials that shed 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 use surgical instruments to grasp the lead or
connector pins.

●

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

●

Inserting the lead using a lead introducer that has a
hemostasis valve may require a larger introducer than the size
recommended. To avoid distortion of the coil electrode, do not
withdraw the lead through a hemostasis valve.

●

Do not implant the lead without first verifying the mechanical
functioning of the helix electrode. Refer to Section 8.2, for
complete instructions.

●

Do not rotate the helix electrode after it is fully extended or fully
retracted. Do not exceed the recommended maximum
number of rotations to extend or retract the helix electrode.
Exceeding the maximum number may result in fracture or
distortion of the inner conductor or helix electrode. The
number of rotations required to fully extend or retract the helix
electrode is variable; refer to Chapter 9 for the recommended
maximum number of rotations.

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

●

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.

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.

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.

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 an MR Conditional device.

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.

Chronic lead removal and the SureScan defibrillation
system – When implanting a SureScan defibrillation 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 defibrillation 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.

5

Note: If a helix does not disengage from the endocardium by
rotating the connector pin, rotating the lead body
counterclockwise may withdraw the helix 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.

AccuRead tool – The AccuRead tool reduces the risk of
connector damage, and reduces the risk of bridging and shorting
that may occur while taking electrical measurements during
implant. The potential for connector damage, bridging, and
shorting is due to variations in analyzer cable terminals, as well as
to the connector ring width and the proximity of the rings on the
DF4 connector.

6 Adverse events and clinical trial data

Information regarding clinical studies and adverse events related
to this lead is available at www.medtronic.com/manuals. The
following clinical studies are related to this lead:

●

Model 6932 RV Lead clinical study

●

Model 6947 RV Lead clinical study

●

Evera MRI System study – This clinical study was executed to
confirm safety and efficacy of the Evera MRI system in the
clinical MRI environment when subjects receive MRI scans up
to 2 W/kg SAR without positioning restrictions (MRI scans
may occur anywhere on the body), providing support for the
Sprint Quattro Secure S MRI SureScan Model 6935M device.

If you do not have web access, a printed copy of the related clinical
study summary can be obtained from your Medtronic
representative, or you can call the toll-free number located on the
back cover.

Potential adverse events – The potential adverse events
associated with the use of transvenous leads and pacing systems
include, but are not limited to, the following events:

●

acceleration of tachyarrhythmias (caused by device)

●

air embolism

●

bleeding

●

body rejection phenomena, including local tissue reaction

●

cardiac dissection

●

cardiac perforation

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cardiac tamponade

●

chronic nerve damage

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constrictive pericarditis

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death

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device migration

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endocarditis

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erosion

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excessive fibrotic tissue growth

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extrusion

●

fibrillation or other arrhythmias

●

fluid accumulation

●

formation of hematomas/seromas or cysts

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heart block

●

heart wall or vein wall rupture

●

hemothorax

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infection

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keloid formation

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lead abrasion and discontinuity

●

lead migration/dislodgement

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mortality due to inability to deliver therapy

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muscle and/or nerve stimulation

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myocardial damage

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myocardial irritability

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myopotential sensing

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pericardial effusion

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pericardial rub

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pneumothorax

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poor connection of the lead to the device, which may lead to
oversensing, undersensing, or a loss of therapy

●

threshold elevation

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thrombosis

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thrombotic embolism

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tissue necrosis

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valve damage (particularly in fragile hearts)

●

venous occlusion

●

venous perforation

Other potential adverse events related to the lead include, but are
not limited to, the following conditions:

●

insulation failure

●

lead conductor or electrode fracture

Additional potential adverse events associated with the use of ICD
systems include, but are not limited to, the following events:

●

inappropriate shocks

●

potential mortality due to inability to defibrillate

●

shunting current or insulating myocardium during
defibrillation

7 Drug information

7.1 Steroid mechanism of action

Steroid suppresses the inflammatory response that is believed to
cause threshold rises typically associated with implanted pacing
electrodes. Dexamethasone sodium phosphate and
dexamethasone acetate are synthetic steroids 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

6