Important Safety Information

An implantable pacemaker system relieves symptoms of heart rhythm disturbances. They do this by restoring normal heart rates. A normal heart rate provides your body with the proper amount of blood circulation. The pacemaker system is intended for patients who need rate-adaptive pacing or chronic pacing or for patients who may benefit from synchronizing the pumping of the heart chambers.

Risks associated with pacemaker system implant include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an implantable pacemaker system, you will have limitations with magnetic and electromagnetic radiation, electric or gas powered appliances, and tools with which you are allowed to be in contact.

A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads are 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. The Revo MRI SureScan pacing system is MR-Conditional. This means the pacing system is designed to allow patients to undergo MRI, when your doctor determines you meet patient eligibility requirements and the scan is conducted according to Medtronic directions.

The Medtronic CareLink Monitor is a prescription device indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. This product is not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to internet connectivity and access, and service availability. The CareLink Home Monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

The Medtronic CareLink Service is prescribed by your physician. This service is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this service, results may vary. For further information, please call the Medtronic toll-free number at 1-800-551-5544 (7:00 a.m. to 6:00 p.m., Monday–Friday, Central Time) or see the Medtronic website at www.medtronic.com.