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11
YEARS
PROVEN
PERFORMANCE
Sprint Quattro™
Defibrillation Leads
PROVEN
PERFORMANCE.
PROVEN
RELIABLE.
We made intentional
choices and took proactive
steps — from lead
design to active product
monitoring — to ensure
reliability of the Sprint
Quattro™ lead family.
Proven by Active Monitoring
Sprint Quattro Secure 6947 lead shows a 95% lead survival rate at 11 years when measured by active monitoring­.
1
™
6947 Sprint Quattro Secure™
PROVEN BY
ACTIVE
MONITORING.
ust Monitoring M
’s Rob
eth
c
i
n
odo
tro
d
log
e
M
y
Device Survival Probability
100
Product
Surveillance
Registry (PSR)
90
80
0
1
2
3
4
5
6
7
8
9
10
11
1 yr
2 yr
3 yr
4 yr
5 yr
6 yr
7 yr
8 yr
9 yr
10 yr
11 yr
%
99.5
99.2
98.9
98.5
98.1
97.5
97.0
96.7
95.9
95.9
95.9
#
2,398
1,994
1,468
819
583
450
356
276
151
66
53
Years of Active In Vivo Data Reported by Manufacturer in Product Performance Report
WE KNOW
QUATTRO’S
ACTUAL
PERFORMANCE
SPRINT QUATTRO™ MODEL 6947
HAS 11 YEARS OF PROVEN
PERFORMANCE1­
BACKED BY A LIFETIME
WARRANTY*2
Returned Product
Analysis (RPA)
CareLink™
Plus
Prospective, non-randomized,
multicenter, global clinical study.
With more than 30 years of
experience and over 75,000
leads evaluated proactively, the
SLS is the largest and longestrunning study of its kind.
Returned Product
Analysis (RPA)
Tracking method which provides
insight into failure mechanisms.
This information is trended
and used to drive future
improvements.
CareLink™ Plus
Program to track ICD lead
integrity on over 25,000 devices,
using the CareLink™ network
and a proprietary algorithm.
Why RPA alone isn’t enough:
*U.S. lead warranty — check with your local sales representative.
Product Surveillance
Registry (PSR)
Only a portion of leads make it back to the manufacturer for analysis
when no longer in use. Some remain in the body and others are
discarded. Returned Product Analysis underestimates lead failure
rates, which is why it is not sufficient to estimate survival. Active
lead monitoring is the best estimate for actual lead survival.
UNMATCHED
MRI ACCESS
TRUE BIPOLAR
PACING AND
SENSING
Sprint Quattro™ leads have
true bipolar pacing and sensing.
True Bipolar Sensing
§ Senses between the lead tip and ring
§ May reduce oversensing due to smaller sensing area3
Integrated Bipolar Sensing
§ Senses between the lead tip and the RV coil
§ May cause potential oversensing due to larger sensing area4
Pair Sprint Quattro Secure™ with a
Medtronic SureScan™ cardiac device today;
provide access to MRI scans tomorrow.
Tip
Ring
Patients with a Sprint Quattro™ MRI SureScan™ lead, coupled
with a Medtronic SureScan™ cardiac device, are now able to
safely undergo an MRI scan when MR conditions for use
are met.
A complete SureScan™ system is required for use in the MR
environment, which includes a Medtronic SureScan™ device
connected to Medtronic SureScan™ leads.
§ DF4 Models: 6947M or 6935M
§ Lead Lengths: 55, 62 cm
§ DF-1 Models: 6947 or 6935
§ Lead Lengths: 58, 65 cm
True Bipolar Sensing
Integrated Bipolar Sensing
RV Electrode
DESIGNED FOR
RELIABILITY.
Purposeful design
decisions were made
to produce a lead
that lasts.
Insulation
High Performance Silicone
ETFE Coating
All silicone is not
the same
§ Used to avoid externalization (creep),
abrasion, and crush
§ Provides a necessary barrier
between the cables and the silicone
Asymmetrical Design Advantage
High-voltage defibrillation cable conductor
Compression lumens
Many types of silicone
were tested and one high
performance silicone was
purposefully selected for the
demands of the Quattro ICD
leads in vivo.
Low-voltage ring electrode cable conductor
Low-voltage helix electrode coil conductor
55D Polyurethane
§ The muscular area of the pocket can put high stresses
on a lead
Compared to a symmetrical lead
design, offsetting the coil and cable
offers several advantages5:
§ A relatively stiff polyurethane (55D) covers the proximal
length to protect against lead crush, lead-to-lead and
lead-to-can abrasion
§ Promotes reduced tip pressure and lead body flexibility
§ Allows for greater insulation thickness between
conductors to help reduce the risk of insulation failure
§ Facilitates increased lead strength allowing room
for two cables (1 cable for Model 6935M) with a
7 x 7 configuration (1 x 19 cable configuration
for Model 6944)
80A Polyurethane
§ In the intercardiac space, forces are less but there is
a greater need for flexibility to accommodate the
movement of the heart
§ A softer, more supple polyurethane (80A) is used as
an overlay between the coils
§ Designed to reduce stresses on the conductors
in a crush situation, allowing for individual
compression lumens to help reduce the risk of failure
DESIGNED FOR
RELIABILITY.
Exclusive Medtronic
Features and Algorithms
created for the
lifetime of the lead.
WITH SMARTSHOCK™
TECHNOLOGY,
WE’VE MADE
THE WHOLE ICD
SYSTEM SMARTER.
Lead Monitoring Algorithms
Lead Integrity Alert (LIA)
Tip seal
designed to reduce fluid ingress
and facilitate reinsertion of a stylet
Monitors the lead at all times to provide advance warning for
lead fracture and extends the VF detection time.
Lead Noise Discrimination and Alert (LNDA)
Identifies oversensing due to noise artifacts, provides ability to
withhold therapy and notifies clinician to potential lead noise.
Solid tip housing
protects internal mechanisms
from damage
Exclusive Medtronic Features
Isoglide™ overlay
Conductor cable to
anode crimp joint
is a reliable connection
produces an isodiametric lead body
facilitating lead passage durability
and lead-to-lead interaction­12
Tensi-Lock™ cable
Blue lead pin
(DF4 models)
provides additional
visual confirmation
during lead insertion
into DF4 header
device
design secures the tip assembly
and provides greater lead strength,6-9
which may aid in the lead extraction10,11
Silicone backfilled
defibrillation electrode
reduces tissue growth­13
Redundant high-voltage
connector
in both RV and SVC defibrillation
electrodes ensure uniform
current distribution14
TOTAL
QUALITY
CONTROL.
The Sprint Quattro™ lead is manufactured in
Medtronic’s facility in Villalba, Puerto Rico.
Components are inspected and certified.
The workforce is trained and certified
every 6 months.
Medtronic’s systems, policies and
procedures limit the variability of products
that are built by human beings.
Quality measures during
manufacturing ensure
you’re consistently
getting a quality product.
OVER 1 MILLION15
SPRINT QUATTRO™
LEADS HAVE
BEEN IMPLANTED
WORLDWIDE.
References
MDT CRHF Product Performance Report 2016, 1st edition. Issue 74.
Updated April 2016. Sprint Quattro 6947 on page 254. http://wwwp.
medtronic.com/productperformance/past-reports.html.
2
#M933759A001 RWA. Limited lifetime warranty, some restrictions may
apply. This warranty is applicable only to Sprint Quattro leads implanted
after December 1, 2008. The limited lifetime warranty applies to the
performance of the lead and includes reimbursement to patients of
unreimbursed medical expenses. The warranty is limited to the provisions
in the written Limited Warranty document that accompanies each product.
Consult the written limited warranty document for details — a copy of
which will be provided to the customer upon request.
3
Sweeney MO, Ellison KE, Shea JB, Newell JB. Provoked and spontaneous
high frequency, low-amplitude, respirophasic noise transients in patients
with implantable cardioverter defibrillators. J Cardiovasc Electrophysiol.
April 2001;12(4):402-410.
4
Weretka S, Michaelsen J, Becker R, et al. Ventricular oversensing: a study of
101 patients implanted with dual chamber defibrillators and two different
lead systems. Pacing Clin Electrophysiol. January 2003;26(1 Pt 1):65-70.
5
Medtronic data on file. August 7, 1997; August 7, 2006; August 2007;
April 9, 2012; August 3, 2012.
1
Medtronic data on file. October 17, 2008.
Medtronic data on file. October 4, 2000.
8
Medtronic data on file. August 7, 1997.
9
Medtronic data on file. November 2, 1995.
10
Smith MC, Love CJ. Extraction of Transvenous Pacing and ICD Leads.
Pacing Clin Electrophysiol. June 2008;31(6):736-752.
11
Wilkoff BL, Al-Khadra AS. The Technique of Transvenous Lead Extraction.
Nonpharmachological Therapy of Arrhythmias for the 21st Century: The
State of the Art. Futura Publishing Co, Inc., Armonk, NY, 1998.
12
Haqqani HM, Mond HG. The implantable cardioverter-defibrillator lead:
principles, progress, and promises. Pacing Clin Electrophysiol.
October 2009;32(10):1336-1353.
13
Singer I, Barold S, Camm J. Nonpharmacological Therapy of
Arrhythmias for the 21st Century: The State of the Art. N Engl J Med.
March 4, 1999;340:740-741.
14
Based on Finite Element Analysis. Medtronic data on file.
15
Vogl H. Total Sales of Sprint Quattro ICD Leads and 5076 pacing leads.
Medtronic data on file. December 2014.
6
7
Brief Statement
Sprint Quattro™ Family of Leads
Indications
Medtronic Sprint Quattro™ leads are intended for pacing and sensing and/
or defibrillation. Defibrillation leads have application for patients for whom
implantable cardioverter defibrillation is indicated.
The Sprint Quattro MRI™ SureScan™ Leads (which include specified lengths
of Models 6935, 6935M, 6947 and 6947M) are part of a Medtronic SureScan™
ICD or CRT-D system. Consult individual lead model technical manuals for
more detail. A complete SureScan™ defibrillation or CRT-D system is required
for use in the MR environment and includes a Medtronic SureScan™ device
connected to Medtronic SureScan™ leads.
Contraindications
The Sprint Quattro™ leads are contraindicated:
§ For the sole use of detection and treatment of atrial arrhythmias
§ In patients with tricuspid valvular disease and/or patients with mechanical
tricuspid heart valves
§ For patients with transient ventricular tachyarrythmias due to reversible
causes (drug intoxication, electrolyte imbalance, sepsis, hypoxia) or other
factors (myocardial infarction, electric shock)
§ In patients for whom a single dose of 1.0 mg of dexamethasone acetate and
dexamethasone sodium phosphate may be contraindicated
Warnings/Precautions
People with metal implants such as pacemakers, implantable cardioverter
defibrillators (ICDs), and accompanying leads should not receive certain
forms of 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. Some lead models allow the use of
therapeutic ultrasound; consult individual lead model technical manuals for
more detail.
Do not use magnetic resonance imaging (MRI) on patients who have non MRconditional versions/lengths of these leads implanted as part of a complete
SureScan™ system. MRI can induce currents on implanted leads, potentially
causing tissue damage and the induction of tachyarrhythmias.
MRI SureScan™ leads only: 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.
Patients and their implanted systems must be screened to meet the following
requirements for MRI: no implanted lead extenders, lead adaptors, or
abandoned leads; no broken leads or leads with intermittent electrical contact
as confirmed by lead impedance history; a SureScan™ defibrillation system
implanted in the left or right pectoral region; pacing capture thresholds of
≤ 2.0 V at a pulse width of 0.4 ms; no diaphragmatic stimulation at a pacing
output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will
be programmed to an asynchronous pacing mode when MRI SureScan is
programmed to On.
Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T
or 3T MRI system for hydrogen proton imaging, maximum spatial gradient ≤
20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s.
1.5T scanners must be operated in Normal Operating Mode (whole body
averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg).
3T scanners must be operated in First Level Controlled Operating Mode or
Normal Operating Mode. B1+RMS must be ≤ 2.8 μT when the isocenter (center of
the bore) is inferior to the C7 vertebra. Scans can be performed without B1+RMS
restriction when the isocenter is at or superior to the C7 vertebra.
Potential Complications
Potential complications include, but are not limited to, acceleration of
ventricular tachycardia, air embolism, bleeding, body rejection phenomena
which includes 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,
muscle and/or nerve stimulation, myocardial damage, myocardial irritability,
myopotential sensing, pericardial effusion, pericardial rub, pneumothorax,
poor connection of the lead to the device, which may lead to oversensing,
undersensing, or a loss of therapy, threshold elevation, thrombosis,
thrombotic embolism, tissue necrosis, valve damage (particularly in fragile
hearts), venous occlusion, venous perforation, lead insulation failure or
conductor or electrode fracture.
MRI SureScan™ leads only: The SureScan™ defibrillation system has been
designed to minimize potential complications in the MRI environment.
Potential MRI complications include, but are not limited to, lead electrode
heating and tissue damage resulting in loss of sensing or capture or both,
or induced currents on leads resulting in continuous capture, VT/VF, and/or
hemodynamic collapse.
See the MRI SureScan™ Technical Manual before performing an MRI Scan
and Lead Technical Manual for detailed information regarding the implant
procedure, indications, contraindications, warnings, precautions, and potential
complications/adverse events. For further information, please call Medtronic at
1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com
or www.mrisurescan.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a
physician.
Medtronic and the Medtronic logo are trademarks of Medtronic.
™
Third party brands are trademarks of their respective owners.
All other brands are trademarks of a Medtronic company.
Brief Statement
MRI SureScan™ ICD and CRT-D
Medtronic SureScan ICD and CRT-D systems are MR Conditional, and as such
are designed to allow patients to undergo MRI under the specified conditions
for use. When programmed to On, the MRI SureScan feature allows the
patient to be safely scanned while the device continues to provide appropriate
pacing. A complete transvenous SureScan system, which is a SureScan device
with appropriate SureScan lead(s), is required for use in the MR environment.
When a single coil SureScan defibrillation lead is used, a Medtronic DF-1 pin
plug must be secured in the SVC port to make a complete SureScan DF-1 ICD
or CRT-D system. 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.
Indications
SureScan ICD systems are indicated to provide ventricular antitachycardia
pacing and ventricular defibrillation for automated treatment of lifethreatening ventricular arrhythmias. In addition, the dual chamber devices are
indicated for use in the above patients with atrial tachyarrhythmias, or those
patients who are at significant risk of developing atrial tachyarrhythmias.
SureScan CRT-D systems are indicated for ventricular antitachycardia pacing
and ventricular defibrillation for automated treatment of life-threatening
ventricular arrhythmias and for providing cardiac resynchronization therapy
in heart failure patients on stable, optimal heart failure medical therapy if
indicated, and meet any of the classifications detailed in the specific device
manuals. New York Heart Association (NYHA) Functional Class III or IV and
who have a left ventricular ejection fraction ≤ 35% and a prolonged QRS
duration. Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms,
left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II. NYHA
Functional Class I, II, or III and who have left ventricular ejection fraction ≤
50% and atrioventricular block (AV block) that are expected to require a high
percentage of ventricular pacing that cannot be managed with algorithms
to minimize right ventricular pacing. Optimization of heart failure medical
therapy that is limited due to AV block or the urgent need for pacing should be
done post implant. Some CRT-D systems are also indicated for use in patients
with atrial tachyarrhythmias, or those patients who are at significant risk for
developing atrial tachyarrhythmias.
Contraindications
SureScan defibrillation ICD and CRT-D systems are contraindicated for
patients experiencing tachyarrhythmias with transient or reversible causes,
or patients with incessant VT or VF. For dual chamber and CRT-D devices, the
device is contraindicated for patients whose primary disorder is chronic atrial
tachyarrhythmia with no concomitant VT or VF. For single chamber devices,
the device is contraindicated for patients whose primary disorder is atrial
tachyarrhythmia.
Warnings and Precautions
Changes in patient’s disease and/or medications may alter the efficacy of
the device’s programmed parameters. Patients should avoid sources of
magnetic and electromagnetic radiation to avoid possible underdetection,
inappropriate sensing and/or therapy delivery, tissue damage, induction
of an arrhythmia, device electrical reset, or device damage. Do not place
transthoracic defibrillation paddles directly over the device. Additionally,
for CRT-D devices, certain programming and device operations may not
provide cardiac resynchronization. Use of the device should not change the
application of established anticoagulation protocols.
Patients and their implanted SureScan ICD and CRT-D systems must be
screened to meet the following requirements for MRI: No lead extenders,
lead adaptors, or abandoned leads present; no broken leads or leads with
intermittent electrical contact as confirmed by lead impedance history;
and the system must be implanted in the left or right pectoral region. For
pacemaker-dependent patients, it is not recommended to perform an MRI
scan if the right ventricular (RV) lead pacing capture threshold is greater
than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an
issue with the implanted lead. No diaphragmatic stimulation at a pacing
output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be
programmed to an asynchronous pacing mode when MRI SureScan is on. It is
not recommended to perform MRI scans during the lead maturation period
(approximately 6 weeks).
MR Scanning Conditions: Patients may be scanned using a horizontal field,
cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging,
maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate
performance per axis ≤ 200 T/m/s. 1.5T scanners must be operated in Normal
Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0
W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in First Level
Controlled Operating Mode or Normal Operating Mode. B1+RMS must be ≤
2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra.
Scans can be performed without B1+RMS restriction when the isocenter is at or
superior to the C7 vertebra.
For SureScan defibrillation and CRT-D systems, continuous patient
monitoring is required while MRI SureScan is programmed to On. Do not
scan a patient without first programming MRI SureScan to On and do not
leave the device in MRI SureScan mode after the scan is complete. While
MRI SureScan is programmed to On, arrhythmia detection and therapies are
suspended, leaving the patient at risk of death from untreated spontaneous
tachyarrhythmia. In addition, if the device is programmed to an asynchronous
pacing mode, arrhythmia risk may be increased.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena,
device migration, infection, or erosion through the skin. Potential
complications associated with cardiac rhythm devices include muscle or
nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia
episodes, acceleration of tachycardia, and surgical complications such as
hematoma, inflammation, and thrombosis. Potential lead complications
include, but are not limited to, valve damage, fibrillation, thrombosis,
thrombotic and air embolism, cardiac perforation, heart wall rupture,
cardiac tamponade, pericardial rub, infection, myocardial irritability, and
pneumothorax. Other potential complications related to the lead may include
lead dislodgement, lead conductor fracture, insulation failure, threshold
elevation, or exit block. Potential MRI complications include, but are not
limited to, lead electrode heating and tissue damage resulting in loss of
sensing or capture or both, or MR-induced stimulation on leads resulting in
continuous capture, VT/VF, and/or hemodynamic collapse.
See the appropriate product MRI SureScan Technical Manual before performing
an MRI Scan and see the device manuals for detailed information regarding the
implant procedure, indications, contraindications, warnings, precautions, and
potential complications/adverse events. For further information, call Medtronic
at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.
com or www.mrisurescan.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of
a physician.
Medtronic
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Toll-free in USA: 800.633.8766
Worldwide: +1.763.514.4000
medtronic.com
UC201302237b EN ©2016 Medtronic.
Minneapolis, MN. All Rights Reserved.
Printed in USA. 12/2016