Sprint Quattro

Indications, Safety, and Warnings

Indications

Medtronic Sprint Quattro^TM 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 (55 cm and 62 cm lengths of Models 6935M or 6947M) are part of the Medtronic SureScan defibrillation system. A complete SureScan defibrillation system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan Leads.

Contraindications

Medtronic leads are contraindicated for the following:

• use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve
• 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 implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive diathermy treatment, except for therapeutic ultrasound. 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 or the need to reprogram or replace the device.
• 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.

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.

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 consult Medtronic’s website at www.medtronic.com or www.mrisurescan.com.

Caution: Swedish law restricts this device to sale by or on the order of a physician.