Could St. Jude ICDs be a Target for Hackers? FDA Issues Safety Advisory

The U.S. Food and Drug Administration today issued a safety advisory regarding St. Jude Medical implantable cardiac devices used in conjunction with St. Jude’s proprietary Merlin @home Transmitter.

According to the advisory, these devices could potentially be vulnerable to hacking. However, only a highly skilled hacker would be sophisticated enough to exploit the vulnerability.  Such unwarranted interference could conceivably cause premature battery depletion or unnecessary shocks.

A software patch has been developed for the Merlin @home monitor designed to address the issue and to reduce the risk of hacking.  The update is now available and will be applied automatically to the Merlin monitor.

***Patients only need to make sure their Merlin@home Transmitter remains plugged in and connected in order to receive the software patch.***

Short-selling firm Muddy Waters first went public with this information in August, believing that it might cause a pending $25 billion acquisition of St. Jude Medical by Abbott Laboratories to fall apart. However, the deal closed last week despite the issue.

See also:

This article on Medscape

This article in the Minneapolis Star Tribune.

This article on Huffington Post.

This article on CNBC.

St. Jude Medical ICD Recall

St. Jude Medical announced today that as many as 400,000  of its Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices manufactured prior to May 23, 2015 are subject to a recall notice due to a risk of premature battery depletion which may render the device unable to deliver a life saving shock.

According to the FDA, the patients most at risk are those who require lifesaving shocks and those who are pacemaker dependent.

The problem has so far resulted in two deaths.

Patients with these devices should contact their physicians for advice about how to proceed, and should seek immediate medical attention if they hear a low-battery alert from their Merlin monitoring device. Continue reading “St. Jude Medical ICD Recall”