MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramImplantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication - Firmware Update to Address Cybersecurity VulnerabilitiesAUDIENCE: Cardiology, Surgery, Family Practice, Patient ISSUE: On August 23, 2017, the FDA approved a firmware update that is now available and is intended as a recall, specifically a corrective action, to reduce the risk of patient harm due to potential exploitation of cybersecurity vulnerabilities for certain Abbott (formerly St. Jude Medical) pacemakers. The firmware update will be available beginning August 29, 2017. Pacemakers manufactured beginning August 28, 2017 will have this update pre-loaded in the device and will not need the update. 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. BACKGROUND: Many medical devices - including St. Jude Medical's implantable cardiac pacemakers - contain configurable embedded computer systems that can be vulnerable to cybersecurity intrusions and exploits. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect how a medical device operates. RECOMMENDATIONS: The firmware update requires an in-person patient visit with a health care provider – it cannot be done from home via Merlin.net. The update process will take approximately 3 minutes to complete. The firmware update process is described in Abbott's Dear Doctor Letter issued on August 28, 2017.
The firmware update process is described in Abbott's Dear Doctor Letter issued on August 28, 2017. Contact your Abbott representative, or Abbott's customer technical support hotline at 1‐800‐722‐3774 if you have any questions about the firmware update. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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