Brief Statement

Medtronic SureScan^® pacing systems, including the Advisa DR MRI^TM and Revo MRI^® SureScan pacing systems, are MR Conditional and as such are designed to allow patients to undergo MRI under the specified conditions for use.

Indications
A complete SureScan pacing system is required for use in the MRI environment.

The Advisa DR MRI^TM SureScan^® Model A2DR01 IPG is indicated for use as a SureScan pacing system consisting of an Advisa DR MRI SureScan IPG implanted with two CapSure Fix MRI^® SureScan 5086MRI leads.
The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a SureScan pacing system consisting of a Revo MRI SureScan IPG with two CapSureFix MRI SureScan 5086MRI leads.

Medtronic SureScan pacing systems are indicated for the following:

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
Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

The systems are 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

Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

Contraindications
Medtronic SureScan pacing systems are contraindicated for:

Concomitant implantation with another bradycardia device
Concomitant implantation with an implantable cardioverter defibrillator

There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient's age and medical condition, however, may dictate the particular pacing system, mode of operation, and implant procedure used by the physician.

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
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 MRI Conditions of Use. Do not scan patients who do not have a complete Medtronic SureScan pacing system consisting of a SureScan device (Advisa MRI or Revo MRI) and two CapSure Fix SureScan leads; patients who have broken or intermittent leads; or patients who have a lead impedance value of < 200 Ω or > 1,500 Ω. Do not scan patients with a SureScan pacing system implanted in sites other than the left or right pectoral region; or patients positioned such that the isocenter (center of MRI bore) is inferior to C1 vertebra and superior to the T12 vertebra.

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 (800) 328-2518 and/or consult Medtronic's website at www.medtronic.com.

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