SPRINT QUATTRO SECURE MRI™ SURESCAN™ 6947
MR Conditional, steroid-eluting, quadripolar, screw-in, ventricular lead with RV/SVC defibrillation coil electrodes
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.
Evera, Evera MRI, Medtronic, Sprint Quattro, Sprint Quattro Secure, Sprint Quattro Secure MRI, SureScan, Tensi-Lock
Contents
1 Description 3
2 Indications 4
3 Drug component description 4
4 Contraindications 4
5 Warnings and precautions 4
6 Drug information 6
7 Pharmacodynamics of the Model 6947 lead 6
8 Adverse events and clinical trial data 7
9 Implant procedure 8
10 Specifications (nominal) 13
11 Medtronic warranty 14
12 Service 14
1 Description
The Medtronic Sprint Quattro Secure MRI SureScan 6947 lead is
a steroid-eluting, quadripolar, screw-in, ventricular lead with right
ventricular (RV) and superior vena cava (SVC) defibrillation coil
electrodes. This lead is designed for pacing, sensing,
cardioversion, and defibrillation therapies. The lead has been
tested for use in the Magnetic Resonance Imaging (MRI)
environment. The following lead lengths are MR Conditional:
58 cm and 65 cm. Other lead lengths are not MR conditional. The
lead also features Tensi-Lock and silicone-backed defibrillation
coils1.
The lead features an extendable and retractable helix electrode,
silicone insulation, and parallel conductors. The 4 electrodes of
the lead are the helix, ring, RV coil, and SVC coil.
●
The tip electrode is common to the connector pin of the IS-1
BI 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-13 connector (red band).
●
The SVC coil electrode is common to the connector pin of the
SVC DF-1 connector (blue band).
The RV and SVC coils deliver 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 trifurcation features a lumen for stylet
passage. The DF-1 connectors do not accept stylets.
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 system
A complete SureScan defibrillation system is required for
use in the MR environment. A complete SureScan system
includes a Medtronic SureScan device with the appropriate
number of Medtronic SureScan leads.The Model 6947 lead is
part of the Medtronic SureScan defibrillation system. Labeling for
SureScan system components displays the SureScan logo and
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.
SureScan logo
MR Conditional symbol. The Medtronic SureScan system is MR Conditional and is designed to allow implanted patients 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,
2
refer to the SureScan system MRI technical manual for
important information about procedures and MRI-specific
warnings and precautions.
1.2 Package contents
Leads and accessories are supplied sterile. Each package
contains the following items:
●
1 lead with 1 radiopaque anchoring sleeve, stylet, and stylet
guide
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1 slit anchoring sleeve
●
1 vein lifter
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2 fixation tools
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2 pin caps
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extra stylets
●
product literature
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
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.
3
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
1.3 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.
Fixation tool – A 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 corresponding lead length.
Stylet guide – A stylet guide facilitates stylet insertion into the
lead.
Vein lifter – A vein lifter facilitates lead insertion into a vein.
2 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.
3 Drug component description
The active ingredients in the 6947 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 each of these steroids is shown below:
Figure 1. Structural formula for dexamethasone sodium phosphate (DSP)
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 dexamethaxone acetate (DXAC)
Dexamethasone acetate is a white to practically white, odorless
powder. Dexamethasone acetate is a practically insoluble ester of
dexamethasone, a synthetic adrenocortical steroid.
The maximum dosage of dexamethasone sodium phosphate and
dexamethasone acetate is less than 1.0 mg per lead.
4 Contraindications
Before performing an MRI scan, refer to the SureScan
system MRI Technical Manual for MRI-specific
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
combined dose of 1.0 mg of dexamethasone sodium phosphate
and dexamethasone acetate may be contraindicated.
4
5 Warnings and precautions
A complete SureScan defibrillation system is required for
use in the MR environment. A complete SureScan
defibrillation system includes a SureScan device with the
appropriate number of SureScan leads. To verify that
components are part of a SureScan system, visit
http://mrisurescan.com. Any other combination may result in a
hazard to the patient during an MRI scan.
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.
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.
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 lead.
For a list of potentially 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 shedding 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 leads in mineral oil, silicone oil, or any
other liquid, except blood, at the time of implantation.
●
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 9 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 10.1 for the
recommended maximum number of rotations.
●
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.
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 SureScan 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
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