Important Safety Information

Implantable Pacemaker System

Additional Device 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.

Risks associated with the Micra Transcatheter Pacing System (Micra) implant include, but are not limited to, complications at the surgical site, injury to the heart where the device is attached such as pericardial effusion (fluid around the heart) 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 a Micra, you will have limitations with certain magnetic and electromagnetic radiation, electric or gas powered appliances and tools in which you are allowed to be in contact.

Once implanted, removal of the Micra after it has become encapsulated may be difficult because of the development of fibrotic tissue.  At such time, your physician has the option of permanently turning off the Micra, and leaving it in the heart.

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.