Cybersecurity: FDA Calls for Firmware Update on Abbott’s Pacemakers

By MedTech Intelligence Staff

The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.

Register to attend the Medical Device Cybersecurity Workshop in person (Boston) or via webcast | October 17–18, 2017 | Learn moreEarlier this week FDA issued a safety communication recommending a firmware update for Abbott’s (formerly St. Jude Medical) implantable cardiac pacemakers. The corrective action should reduce the risk of patient harm as a result of cybersecurity vulnerabilities related to the company’s Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure pacemakers. The FDA and Abbott do not recommend removal or replacement of the affected devices.

“The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient’s physician) to access a patient’s device using commercially available equipment. This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.” – FDA

The firmware update takes about three minutes and requires an in-person patient visit with a healthcare provider, according to FDA.


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