SPRINT QUATTRO® 6944
Steroid eluting, quadripolar, ventricular lead with tined
tip and RV/SVC coil electrodes
Technical manual
Caution: Federal Law (USA) restricts this
device to sale by or on the order of a
physician.
The following are trademarks of Medtronic:
Medtronic and Sprint Quattro
Contents
Device description 5
Contents of package 5
Accessory descriptions 6
Indications for use 6
Contraindications 6
Warnings and precautions 7
Adverse events 9
Observed adverse events 9
Potential adverse events 11
Clinical studies 11
Directions for use 15
Opening the package 15
Inserting the lead 16
Positioning the lead 17
Taking electrical measurements and defibrillation efficacy
measurements 18
Anchoring the lead 20
Connecting the lead 21
Placing the device and leads into the pocket 21
Post-implant evaluation 22
Detailed device description 22
Specifications (nominal) 22
Specifications drawing (nominal) 23
Special notice 24
Service 24
6944 Technical Manual 3
Device description
The Medtronic Sprint Quattro Model 6944 steroid eluting,
quadripolar, ventricular lead with tined tip and right ventricular (RV)
and superior vena cava (SVC) coil electrodes is designed for pacing,
sensing, cardioversion, and defibrillation therapies.
The lead features tines, silicone insulation with overlay, and parallel
conductors. The four electrodes of the lead are tip, ring, RV coil, and
SVC coil:
■
The tip electrode is common to the connector pin of the
IS-1 BI connector.
■
The ring electrode is common to the connector ring of the
IS-1 BI connector.
■
The RV coil electrode is common to the connector pin of the
RV DF-1 connector (red band).
■
The SVC coil electrode is common to the connector pin of the
SVC DF-1 connector (blue band).
1
The IS-1
passage. The DF-1
The RV and SVC coils deliver cardioversion and defibrillation
therapies. Pacing and sensing occur between the tip and
ring electrodes.
The steroid dexamethasone sodium phosphate is located on the tip
electrode surface. The tip electrode also incorporates a steroid
eluting plug containing dexamethasone acetate. The tip electrode
contains a maximum of 1.0 mg of dexamethasone steroid. Exposure
to body fluids elutes the steroid 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.
bipolar leg of the trifurcation features a lumen for stylet
2
connectors will not accept stylets.
Contents of package
The lead and accessories are provided sterile. Each package
contains the following:
■
One lead with one3 radiopaque anchoring sleeve, stylet,
stylet guide
■
One vein lifter
■
One slit anchoring sleeve
■
Extra stylets
■
Pin caps
■
Product literature
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 anchoring sleeves are provided with leads 85 cm or longer.
6944 Technical Manual English 5
Accessory descriptions
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.
Anchoring sleeves – An anchoring sleeve secures the lead from
moving and protects the lead insulation and conductors from damage
caused by tight ligatures.
Slit anchoring sleeve – A slit anchoring sleeve secures excess lead
length in the device pocket.
Pin cap – A pin cap covers and insulates unused connector pins.
Vein lifter – A vein lifter facilitates lead insertion into a vessel.
Indications for use
The lead is intended for single, long-term use in the right ventricle.
This lead has application for patients in which implantable
cardioverter defibrillators are indicated.
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 may be contraindicated.
6 English 6944 Technical Manual
Warnings and precautions
Inspecting the sterile package – Inspect the package prior
to opening:
■
If the seal or package is damaged, contact your local
Medtronic representative.
■
Do not use the product after its expiration date.
Ethylene oxide resterilization – The lead has been sterilized with
ethylene oxide prior to shipment. If the integrity of the sterile package
has been compromised prior to the expiration date, resterilize using
ethylene oxide. Avoid resterilization techniques that could damage
the lead:
■
Refer to sterilizer instructions for operating instructions.
■
Use an acceptable method for determining sterilizer
effectiveness, such as biological indicators.
■
Before resterilization, remove the disk tip protector, and place
the device in an ethylene oxide permeable package.
■
Do not exceed temperatures of 55°C (130°F).
■
Do not resterilize more than one time.
■
After resterilization, allow the device to aerate ethylene
oxide residues.
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 implantation of the system.
Steroid elution – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone apply to the use of this highly localized,
controlled-release device. For a listing of potentially adverse effects,
refer to the Physicians’ Desk Reference.
Handling the steroid tip – Reducing the available amount of steroid
may adversely affect low-threshold performance. Avoid reducing the
amount of steroid available prior to lead implantation:
■
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 implantation.
6944 Technical Manual English 7
Handling the lead – Leads should be handled with great 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 leads in mineral oil, silicone oil, or any other
liquid, except blood at the time of implantation.
■
Inserting the lead using a lead introducer that features a
hemostasis valve may require a larger introducer than the size
recommended. Do not withdraw the lead through a hemostasis
valve, to avoid distortion of the coil electrode.
Handling the stylets – Use care when handling stylets:
■
Do not use excessive force or surgical instruments when
inserting a stylet.
■
Avoid overbending, kinking, or blood contact.
■
Use a new stylet when blood or other fluids accumulate on the
stylet. Accumulated fluids may cause lead damage or difficulty
in passing the stylet through the lead.
■
Do not use a sharp object to impart a curve to the distal end of
the stylet.
Necessary hospital equipment – Keep external defibrillation
equipment nearby for immediate use during the acute lead system
testing, implantation procedure, or whenever arrhythmias are
possible or intentionally induced during post-implant testing.
Line-powered equipment – An implanted lead forms a direct
current path to the myocardium. During lead implantation 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 85 cm or longer feature two
anchoring sleeves. Use both anchoring sleeves to assure adequate
fixation, see the section “Anchoring the lead.”
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.
8 English 6944 Technical Manual
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