Indications, Safety, and Warnings
Indications
Medtronic MRI SureScan™ pacing leads have application where implantable atrial and/or ventricular, single or dual chamber pacing systems are indicated. Leads are intended for pacing and sensing in the right atrium and/or ventricle. MRI SureScan™ leads (which include specified lengths of Models 5076, 4076, 4074, 4574, and 5086MRI; consult individual lead model technical manuals for more detail) are indicated for use as a system consisting of a Medtronic MRI SureScan™ IPG, ICD, or CRT devices implanted with SureScan™ leads. A complete system is required for use in the MRI environment.
Contraindications
Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease and/or patients with mechanical tricuspid heart valves. Do not use in patients for whom a single dose of dexamethasone acetate may be contraindicated (see lead 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. 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.
A complete SureScan™ pacing 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™ pacing 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. It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks).
IPG specific: pace polarity parameters set to Bipolar for programming MRI SureScan™ to On (Advisa MRI only); or a SureScan™ pacing system with a lead impedance value of ≥ 200 Ω and ≤ 1500 Ω. Revo MRI patients must have pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms and a SureScan™ pacing system that has been implanted for a minimum of 6 weeks.
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 adverse events
Potential patient-related complications related to the use of transvenous leads include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential lead-related complications may include exit block, lead dislodgement, lead fracture, insulation failure, and threshold elevation.
The SureScan™ pacing, ICD, or CRT 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 appropriate Device 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 (United States) restricts these devices to sale by or on the order of a physician.
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