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Important Safety Information

Bradycardia (Slow Heart Rate)


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 MRI SureScan Pacemaker 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.

This treatment is prescribed by your physician. This treatment 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 treatment, results may vary.