Important Safety Information Aurora EV-ICD System

An implantable defibrillation (ICD) 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 defibrillation system is intended for patients who are at risk for a potentially life-threatening heart rhythm.

Risks associated with a defibrillation system 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 defibrillation system, you may have limitations with magnetic and electromagnetic radiation, electrical or gas-powered appliances, and tools with which you are allowed to be in contact.

A complete Aurora Extravascular Implantable Cardiac Defibrillation (EV-ICD) MRI SureScan system consists of a specified combination of an Aurora EV-ICD device with the corresponding Epsila lead. Any other combination of device and lead could result in the inability for the device to function and lead to patient harm.

When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate defibrillation therapy. The Aurora EV-ICD MRI SureScan system is MR conditional. This means the defibrillation 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.

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.

For further questions or additional information, please call the Medtronic toll-free number at 800-551-5554 (7:00 a.m. to 6:00 p.m., Monday-Friday, Central time) or see the Medtronic website at

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