ISSUE: On April 11, 2018, the FDA approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities for certain Abbott ICDs and CRT-Ds. “Firmware” is a specific type of software embedded in the hardware of a medical device (e.g. a component in the defibrillator).
This firmware update includes mitigations to addresses two separate issues: 1) a device-based Battery Performance Alert to detect rapid battery depletion in devices subject to the Battery Advisory from October 2016; and 2) updates to address cybersecurity vulnerabilities across Abbott’s radio frequency (RF) enabled ICDs and CRT-Ds.
Review the Safety Communication for full details on the issue and product identification.
BACKGROUND: Abbott’s (formerly St. Jude Medical) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires (“leads”) that go into the heart. A patient may need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
RECOMMENDATION: The FDA recommends that all eligible patients receive the firmware update at their next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. Review the Safety Communication for more details on recommendations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[04/17/2018 – Safety Communication – FDA]