Abbott Advisory Regarding Battery Performance and Firmware Update

The US Food and Drug Administration (FDA) issued a Medical Device Safety Communication announcing a firmware update that addresses 2 previously reported safety concerns. The update includes a battery performance alert and improved cybersecurity for certain high voltage implantable cardiac devices (ICDs and CRT-Ds). Abbott has sent a medical device advisory to physicians making them aware of the firmware update.

It is recommended that all eligible patients receive the firmware update at their next scheduled visit or when appropriate depending upon the preferences of the patient and physician. FDA and Abbott advise that prophylactic removal and replacement of affected devices is NOT recommended.

The firmware update applies to devices affected by the October 11, 2016 advisory and incorporates the Battery Performance Alert (BPA) for device-based detection of abnormal battery performance due to lithium cluster induced shorts in the Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices manufactured between January 2010 and May 2015. If BPA is triggered, a vibratory notification is delivered to the patient. An alert also will be sent to the physician via the Merlin.net remote monitoring system and during follow-up evaluations. The upgrade process takes approximately three minutes complete.

The firmware update also addresses identified cybersecurity vulnerabilities. To date, Abbott has not received any reports of device compromise due to these cybersecurity risks.

For questions related to this device firmware updates, physicians are advised to contact their Abbott representative or the Abbott customer technical support hotline at 1-800-436-5056. Additional materials including patient communication materials can be found on www.sjm.com/notices .

Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit a report online at www.fda.gov/medwatch/report.htm .
• Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm . Forms may be mailed or faxed. Follow instructions on form.