Defibrillator leads

Sprint Quattro™ defibrillator lead

The Sprint Quattro™ defibrillator lead is used in tachyarrhythmia management.

Indications, Safety, and WarningsIndications 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, 6947M, and 6946M) 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. Contraindictions The Sprint Quattro™ leads are contraindicated as described:

Atrial use — for the sole use of detection and treatment of atrial arrhythmias

Ventricular use — for ventricular use in patients with tricuspid valvular disease 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)

Do not use in patients for whom a single dose of dexamethasone acetate and/or dexamethasone sodium acetate may be contraindicated (applies to all leads that contain these steroid configurations). See model manuals for specific dosage.Warnings and precautions People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. 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-MR Conditional 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 tachyarrhythmiasMRI 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. See the lead technical manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.Caution
Federal law (United States) restricts this device to sale by or on the order of a physician.Rev 0417MAJ_83933

Features

Designed for reliability¹

Purposeful design decisions were made to produce a lead that lasts.
From the asymmetrical design to the material selection, the Sprint Quattro™ defibrillator lead was designed for reliability and tested in a variety of different ways to withstand in vivo conditions.

Proven by active, clinical monitoring

The Sprint Quattro Secure™ 6947 lead shows a 86.9% lead survival rate at 20 years when measured by active, clinical monitoring.¹

MRI access

Specific lengths of the Sprint Quattro™ defibrillator lead portfolio are approved for use in the MR environment. Patients with a Sprint Quattro™ MRI SureScan™ lead, coupled with a Medtronic SureScan™ cardiac device, are 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.

DF-1 Models:

6935 and 6947
Lead lengths: 58 cm, 65 cm

DF4 Models: 

6935M, 6946M, and 6947M
Lead lengths: 55 cm, 62 cm

Ordering information

Item number	Type	Fixation	Connector	MR Conditional lengths (cm)
6935	Single coil, tripolar	Helix, active fixation	Unipolar, DF-1	58, 65
6935M	Single coil, tripolar	Helix, active fixation	Quadripolar, DF4	55, 62
6947	Dual coil, quadripolar	Helix, active fixation	Unipolar, DF-1	58, 65
6947M	Dual coil, quadripolar	Helix, active fixation	Quadripolar, DF4	55, 62
6946M	Dual coil, quadripolar	Tined, passive fixation	Quadripolar, DF4	55, 62