INDICATIONS

The Advisa DR MRI and Advisa SR MRI SureScan systems are indicated for the rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity. Accepted patient conditions warranting chronic cardiac pacing include symptomatic paroxysmal or permanent second- or third-degree AV block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, or bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias.

The Advisa DR MRI device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output, VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm, or vasovagal syndromes or hypersensitive carotid sinus syndromes. Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

CONTRAINDICATIONS

The Advisa DR MRI and Advisa SR MRI SureScan systems are contraindicated for concomitant implantation with another bradycardia device or with an implantable cardioverter defibrillator. Rate-responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate. Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter. Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms. Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance. ATP therapy is contraindicated in patients with an accessory antegrade pathway.

WARNINGS AND PRECAUTIONS

Changes in 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. Use of the device should not change the application of established anticoagulation protocols.

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; the device must be operating within the projected service life, and the system must be implanted in the left or right pectoral region. Pace polarity parameters are set to Bipolar for programming MRI SureScan to On; or a SureScan pacing system is implanted with a lead impedance value of ≥ 200 Ω and ≤ 1,500 Ω. It is not recommended to perform MRI scans during the lead maturation period (approximately 6 weeks).

For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. Patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on must have no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms.

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. B_1+RMS must be ≤ 2.8 μT when the isocenter (center of the bore) is inferior to the C7 vertebra. Scans can be performed without B_1+RMS restriction when the isocenter is at or superior to the C7 vertebra. Continuous patient monitoring is required during the MRI scan.

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, 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. The SureScan 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 device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1-800328-2518 and/or consult the Medtronic website at www.medtronic.com.

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