Medtronic 6935 Technical Manual

SPRINT QUATTRO SECURE S™ 6935

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 are trademarks or registered trademarks of Medtronic in the United States and possibly in other countries:

Medtronic, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Secure S

Contents

1 Description 3
2 Drug component description 3
3 Indications 4
4 Contraindications 4
5 Warnings and precautions 4
6 Potential complications 5
7 Drug Information 6
8 Adverse events and clinical trial data 6

9 Implant procedure 6
10 Specifications (nominal) 11
11 Medtronic warranty 12
12 Service 12

1 Description

The Medtronic Sprint Quattro Secure S Model 6935 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 lead features an extendable/retractable helix electrode,
silicone insulation with overlay, and parallel conductors. The 3
electrodes of the lead are the helix, ring, and RV coil. The ring and
helix electrodes are platinized. See Figure 13 for an illustration of
the lead.

●

The helix electrode is common to the connector pin of the
IS-11 BI pin connector.

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The ring electrode is common to the connector ring of the IS-1
BI connector.

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The RV coil electrode is common to the connector pin of the
RV DF-12 connector (red band).

The RV coil delivers cardioversion and defibrillation therapies.
Pacing and sensing occur between the helix and ring electrodes.

The helix electrode is made of platinized platinum alloy that can
be actively fixed into the endocardium. The helix electrode can
be extended or retracted by rotating the IS-1 connector pin with
the fixation tool.

The IS-1 bipolar leg of the bifurcation features a lumen for stylet
passage. The DF-1 connector legs will not accept a stylet.

The distal tip of the lead contains a maximum of 1.0 mg
dexamethasone sodium phosphate. 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.

1.1 Package contents

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

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1 lead with 1 radiopaque anchoring sleeve3, stylet, and stylet
guide

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2 fixation tools

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1 slit anchoring sleeve

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1 vein lifter

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2 pin caps

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extra stylets

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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.

Fixation tool – The fixation tool facilitates connector pin rotation.

Pin cap – A pin cap covers and insulates unused connector pins.

Slit anchoring sleeve – A slit anchoring sleeve secures excess

lead length in the device pocket.

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

The active ingredient in the Model 6935 lead is dexamethasone
sodium phosphate [9-fluoro-11β,
17-dihydroxy-16α-methyl-21-(phosphonooxy)
pregna-1,4-diene-3,20-dione disodium salt]. Dexamethasone
sodium phosphate (DSP) is an inorganic ester of
dexamethasone, a synthetic adrenocortical steroid. DSP is a
white or slightly yellow crystalline powder. It is freely soluble in
water and is very hygroscopic.

The structural formula for this steroid is shown below.

1

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

2

DF-1 refers to the International Connector Standard (ISO 11318) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

3

Two radiopaque anchoring sleeves are provided with leads 85 cm or longer.

3

Figure 1. Structural formula for dexamethasone sodium
phosphate C22H28FNa2O8P

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

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 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 – Use of steroid eluting transvenous leads is
contraindicated in patients for whom a single dose of 1.0 mg
dexamethasone sodium phosphate may be contraindicated.

5 Warnings and precautions

Line-powered and battery-powered equipment – An

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

Diathermy – People with metal implants such as pacemakers,
implantable cardioverter defibrillators (ICDs), and accompanying
leads should not receive diathermy treatment. The interaction

between the implant and diathermy can cause tissue damage,
fibrillation, or damage to the device components, which could
result in serious injury, loss of therapy, and/or the need to
reprogram or replace the device.

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

Single use – The lead is for single use only.

Inspecting the sterile package – Inspect the sterile package

with care before opening it.

●

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

●

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

●

Do not use the product after its expiration date.

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

Steroid use – 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.

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.

Drug interactions – Drug interaction of dexamethasone sodium
phosphate with this lead has not been studied.

Use of multiple leads – Prior to implanting the lead, total patient
exposure to dexamethasone sodium phosphate should be
considered.

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.

4

●

Inserting the lead using a lead introducer that features 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 9.2,
“Verifying the mechanical functioning of the helix electrode”,
page 7, for complete instructions.

●

Do not rotate the helix electrode after it is fully extended or
fully retracted. The number of rotations required to fully
extend or retract the helix electrode is variable.

●

Furthermore, 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. Refer to
Section 10 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.

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

Chronic repositioning or removal of a screw-in lead –

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 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.

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

Second anchoring sleeve – Leads 85 cm or longer feature
2 anchoring sleeves. Use both anchoring sleeves to assure
adequate fixation.

Connector compatibility – Although the lead conforms to the
International Connector Standards IS-1 and DF-1, 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.

6 Potential complications

The potential complications 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:

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cardiac perforation

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cardiac tamponade

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constrictive pericarditis

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embolism

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endocarditis

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fibrillation or other arrhythmias

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heart wall rupture

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hemothorax

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infection

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pneumothorax

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thrombosis

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tissue necrosis

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

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insulation failure

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lead conductor or electrode fracture

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lead dislodgment

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

5