FDA Safety Communication for Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical)

PUBLISHED: Apr 17, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office

On April 11, 2018, the U.S. Food and Drug Administration (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.

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.

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. Follow the link below 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.

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