Medtronic MRI ICD and Sprint Quattro Leads Brief Statement
Indications
ICD: Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Some ICDs are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.
Lead: 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.
MRI SureScan products only: Medtronic SureScan systems are MR Conditional, and as such are designed to allow patients to undergo MRI under the specified conditions for use. Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging. When SureScan systems are programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing. A complete SureScan system, which is a SureScan device with appropriate SureScan lead(s), is required for use in the MR environment. 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.
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 system. Consult individual lead model technical manuals for more detail.
Contraindications
ICD: ICD systems are contraindicated in patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF.
Lead: 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.
· Do not use in patients for whom a single dose of dexamethasone acetate and/or dexamethasone sodium acetate may be contraindicated
Warnings and Precautions
ICD: Changes in a 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. People with metal implants such as pacemakers, (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.
Lead: 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 Systems only: Patients and their implanted 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.
Potential Adverse Events
Potential adverse events 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 product implant 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 Medtronic’s 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