FDA Okays Firmware Update for Abbott ICD, CRT-D Battery, Security Glitches

Disclosures

April 17, 2018

Abbott has made a firmware update available that addresses previously identified battery-depletion and cybersecurity issues in certain families of its cardiac electronic implantable devices (CIEDs), the US Food and Drug Administration (FDA) has announced.

The agency approved the update as a "recall" corrective action recommended for all patients with the affected devices. It can't be implemented remotely, so patients must visit their provider to receive the update.

The devices covered by the corrective action include implantable cardioverter defibrillators (ICDs) and cardiac-resynchronization therapy defibrillators (CRT-Ds) from Abbott, which acquired St Jude Medical in January 2017, in the following families: Current, Promote, Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra, and Ellipse.

Pacing-only devices are not included in the corrective action.

The firmware update provides the devices with a Battery Performance Alert to warn of rapid battery depletion in devices that were subject to a safety alert issued in October, 2016. As reported at the time, there were some cases of full battery drainage that could potentially have compromised the ability to deliver shocks.

The update also includes an FDA-approved patch designed to avert unauthorized access to the device's programming, a vulnerability identified in the company's radiofrequency-enabled CIEDs. "After installing this update, any device attempting to communicate with the implanted defibrillator must provide authorization to do so, according to the agency.

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