The FDA has approved a firmware update aimed at addressing two previously reported issues with some of Abbott’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
The updates target a premature battery depletion problem and cybersecurity vulnerabilities, although no unauthorized access to patients’ devices has been reported.
First reported in October 2016, the battery drainage issue was linked to at least two patient deaths and involved several lines of devices manufactured by St. Jude Medical, which was later acquired by Abbott. According to the FDA’s safety communication, lithium deposits could form on the batteries and cause them to lose their power within a day—preventing the batteries from delivering life-saving shocks.
The firmware update adds a battery performance alert if rapid battery depletion is detected.
The FDA said the update takes about three minutes to complete and recommended “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.”
In a press release, Abbott said the following families of ICDs and CRT-Ds can be updated: Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.