SPRINT QUATTRO® 6946M
Dexamethasone acetate steroid eluting, quadripolar, ventricular lead with tined tip and 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.
AccuRead, Medtronic, Sprint Quattro, Tensi-Lock
Contents
1 Device description 3
2 Drug component description 3
3 Indications 4
4 Contraindications 4
5 Warnings and precautions 4
6 Potential adverse events 5
7 Clinical data 6
8 Drug information 6
9 Directions for use 7
10 Specifications (nominal) 11
11 Medtronic warranty 12
12 Service 12
13 Explanation of symbols on package labeling 12
1 Device description
The Medtronic Sprint Quattro Model 6946M lead is a
steroid-eluting, quadripolar, tined tip, 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 features tines, silicone insulation with overlay, parallel
conductors, tip and ring electrodes, and RV and SVC coils. The
lead also features Tensi-Lock1 and silicone-backfilled
defibrillation coils.
The DF4-LLHH2 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 and SVC coils deliver cardioversion and defibrillation
therapies. Pacing and sensing occur between the tip and
ring electrodes. An AccuRead analyzer cable interface tool (ACI
tool) is attached to the lead to facilitate accurate electrical
measurements during implant.
The tip electrode contains a steroid-eluting plug that contains
dexamethasone acetate. The tip electrode contains a nominal
dosage of 272 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.
1.1 Package contents
Leads and accessories are supplied sterile. Each package
contains the following items:
●
1 lead with a radiopaque anchoring sleeve3, stylet, and
AccuRead tool
●
1 purple stylet guide
●
1 slit anchoring sleeve
●
1 vein lifter
●
extra stylets
●
product literature
1.2 Accessory descriptions
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 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.
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 6946M lead is
dexamethasone acetate 9-Fluoro-11β,
17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione
21-acetate. The structural formula for this steroid is shown below:
Dexamethasone acetate is a white to off-white, odorless powder
(USP) that is a practically insoluble in aqueous solutions.
Dexamethasone acetate is a synthetic adrenocortical steroid
produced by the esterification of dexamethasone.
Structural formula for dexamethasone acetate (DXAC) C24H31FO
6
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-LLHH refers to the International Connector Standard ISO 27186:2010, where the lead connector contacts are defined as low voltage (L) or high voltage (H).
3
Two radiopaque anchoring sleeves are provided on leads that are 85 cm or longer.
3
Figure 1.
The nominal dosage of dexamethasone acetate is 272 µg 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 (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 272 µg of dexamethasone acetate may
be contraindicated.
5 Warnings and precautions
Inspecting the sterile package – Inspect the sterile package
with care before opening it.
●
Contact a Medtronic representative if the seal or package is
damaged.
●
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.
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
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 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 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.
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.
4
●
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.
Second anchoring sleeve – Leads that are 85 cm or longer
include 2 anchoring sleeves. Use both anchoring sleeves to
assure adequate fixation.
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. Do not conduct MRI scans on patients who have
this device or lead implanted. MRI scans may result in serious
injury, induction of tachyarrhythmias, or implanted system
malfunction or damage.
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 repositioning or removal – Chronic repositioning or
removal of leads may be difficult because of fibrotic tissue
development. Return all removed leads, or lead segments, to
Medtronic. If a lead must be removed or repositioned, proceed
with extreme caution.
●
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 may adversely affect the low-threshold
performance of a steroid-eluting 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 Potential adverse events
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
●
cardiac tamponade
●
chronic nerve damage
●
constrictive pericarditis
●
death
●
device migration
●
endocarditis
●
erosion
●
excessive fibrotic tissue growth
●
extrusion
●
fibrillation or other arrhythmias
●
fluid accumulation
●
formation of hematomas/seromas or cysts
●
heart block
●
heart wall or vein wall rupture
●
hemothorax
●
infection
●
keloid formation
●
lead abrasion and discontinuity
●
lead migration/dislodgement
●
mortality due to inability to deliver therapy
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muscle and/or nerve stimulation
●
myocardial damage
●
myocardial irritability
●
myopotential sensing
●
pericardial effusion
●
pericardial rub
5
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