INDICATIONS, SAFETY, AND WARNINGS Sprint Quattro Defibrillator Lead Portfolio

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, 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. 


Contraindications

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 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 Medtronic.com  or MRISureScan.com

Caution:  Federal law (USA) restricts this device to sale by or on the order of a physician.

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