August 29, 2017
Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication
- Patients with a radio frequency (RF)-enabled St. Jude Medical implantable pacemaker
- Caregivers of patients with an RF-enabled St. Jude Medical implantable cardiac pacemaker
- Cardiologists, electrophysiologists, cardiothoracic surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems using an RF-enabled St. Jude Medical implantable cardiac pacemaker
Cardiac Electrophysiology, Cardiology, Cardiothoracic Surgery, Heart Failure
Abbott’s (formerly St. Jude Medical’s) implantable cardiac pacemakers, including cardiac resynchronization therapy pacemaker (CRT-P) devices, provide pacing for slow or irregular heart rhythms. These devices are implanted under the skin in the upper chest area and have connecting insulated wires called “leads” that go into the heart. A patient may need an implantable cardiac pacemaker if their heartbeat is too slow (bradycardia) or needs resynchronization to treat heart failure.
The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices:
- Accent MRI
- Accent ST
This communication does NOT apply to any implantable cardiac defibrillators (ICDs) or to cardiac resynchronization ICDs (CRT-Ds).