The U.S. Food and Drug Administration (FDA) recently approved a firmware update for certain Abbott implantable cardiac devices to reduce the risk of patient harm due to battery performance and cybersecurity vulnerabilities. The Abbott ICDs and CRT-Ds, which are powered by lithium-based batteries, may develop lithium clusters within the battery leading to rapid battery failure, leaving the device unable to deliver pacing or shocks. The firmware update includes a device-based Battery Performance Alert to detect and alert patients and clinicians if their device is affected. The update also addresses the cybersecurity vulnerabilities associated with configurable embedded computer systems with an authorization requirement in order to communicate with the devices. Patients with devices unable to accept the update can choose to permanently disable radio frequency, although it will also prevent the transmission of data from the device to the doctor's office through the RF Merlin@home Transmitter. The firmware update cannot be conducted at home, and takes approximately three minutes to complete while the device operates in backup mode.

Access the full list of affected devices and the full safety communication here.

Keywords: ACC Advocacy, Lithium, Patient Harm, Neurofibromin 2, United States Food and Drug Administration, Electric Power Supplies, Defibrillators, Implantable, Computer Security, Computer Systems

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