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.

Abandoned Leads Harder to Extract

According to a recent study published in JACC: Clinical Electrophysiology, previously abandoned pacemaker and implantable defibrillator leads which have been capped off and left behind following replacement were harder to extract later.  These abandoned leads also made it more difficult to treat device infections.

When interviewed about the significance of these study results, several physicians knowledgeable in the field further emphasized that lead removal requires special skill and equipment not typical for the average physician who implants cardiac devices.  Hence, patients facing a potential lead extraction should consider their options carefully and seek care from a specialist in lead extraction.