FDA issues safety alert on implantable cardiac devices, transmitters by St Jude Medical

Editor's Note

The Food and Drug Administration on January 9 issued a safety alert for St Jude Medical’s (St Paul, Minnesota) radio frequency-enabled implantable cardiac devices and Merlin@home transmitters on reducing the risk of patient harm from cybersecurity vulnerabilities.

The vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s cardiac device by altering the transmitter. The transmitter could then be used to modify programming commands to the device, which could result in rapid battery depletion and administration of inappropriate pacing or shocks.

To improve safety, St Jude Medical has developed a software patch for the transmitter that reduces the risk of cybersecurity vulnerabilities. The patch was made available January 9.

Posted 01/09/2017] AUDIENCE: Cardiology, Surgery, Family Practice, Patient ISSUE: The FDA is providing information and recommendations regarding St. Jude Medical's radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St.