SILVER SPRING, Md. – The U.S. Food and Drug Administration issued a notice that cybersecurity vulnerabilities have been identified in St. Jude Medical’s implantable cardiac devices and the Merlin@home Transmitter. “The FDA has reviewed information concerning cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home Transmitter 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 RF-enabled implanted cardiac device by altering the Merlin@home Transmitter,” the notice said. The Transmitter could then be used to modify programming commands to the implanted device, which could result in rapid battery depletion or administration of inappropriate pacing or shocks, said the FDA. St. Jude Medical has developed a software patch that addresses and reduces the risk of cybersecurity vulnerabilities.
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