Implantable Cardiac Devices, Programmers, and Home Monitors by Medtronic: Safety Communication - Cybersecurity Vulnerabilities

A new MedWatch Safety Alert was just added to the FDA Medical Devices web page.  TOPIC: Implantable Cardiac Devices, Programmers, and Home Monitors by Medtronic: Safety Communication - Cybersecurity Vulnerabilities   AUDIENCE: Cardiology, Patient, Health Professional ISSUE: FDA is issuing this safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. The FDA recommends that health care providers and patients continue to use these devices as intended and follow device labeling. Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities. To date, the FDA is not aware of any reports of patient harm related to these cybersecurity vulnerabilities.

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