Hazards and Risks

Three powerful fields present during MRI scanning provide sources of electromagnetic interference (EMI):

Static magnetic field
Gradient magnetic field
Pulsed radiofrequency (RF) field

Either alone or in combination, these fields have the potential to induce hazardous effects on patients and their implantable
cardiac devices.

A combination of variables affects the magnitude of risk for patients

Type of imaging sequence
Patient and device position within the scanner
Duration of MRI scan
Strength of RF field
Target anatomy of scan
Pacemaker and lead materials and design
Length and anatomical orientation of pacing leads
Blood flow in lead tip region
Patient factors and medical history

Because of these risks, MRI scans are contraindicated and off limits for millions of patients with implantable cardiac devices.

Numerous adverse events involving pacemaker patients undergoing MRI scans have been reported by the FDA and in medical journals.¹³

The Revo MRI SureScan Pacing System has undergone extensive preclinical evaluation and a confirmatory clinical trial to provide safe access to the MRI environment. Testing has been limited on current pacing systems, and studies have been too small and insufficient to extrapolate results to the larger population.

Revo MR Conditional Risk Information

A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use in the MRI environment
Any other pacing system combination may result in a hazard to the patient during an MRI scan
When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing
Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronics website at www.medtronic.com or call Medtronic at 1 (800) 328-2518.