Product News and Recalls

St. Jude Medical Inc Tells Doctors to Stop Implanting Its Devices

st. jude medical advises doctors to stop implanting monitorsShortly after warning patients that their implanted heart defibrillators were having battery problems and may not work when needed, St. Jude Medical Inc. (no relation to the St. Jude Children’s Research Hospital) has advised doctors to stop implanting their devices for a separate and unrelated reason.

Concerns over St. Jude defibrillators initially focused on the units’ batteries depleting faster than they should. This would result in a needed shock coming in at less power than what was required, or not occurring at all.

At the same time, concerns have been raised over the security of the devices themselves. As more and more electronic devices join the Internet of Things, concerns continue to grow over hacking and other intrusions. While the hacking claim is still under investigation and may have been spawned under less than altruistic circumstances, the battery concern is very real and has already led to hospitalizations and fatalities.

In a new statement issued late last month, however, it was revealed that other St. Jude Medical units were suffering power losses resulting in a loss of device telemetry. Put a bit more simply, it means that the devices were no longer recording what they were doing nor what they were put in place to monitor, thus making that information inaccessible to the doctors that need it.

The devices are part of the Nanostim line of St. Jude pacemakers. Reuters reports that 1,423 Nanostims have been implanted in patients around the world. 1,397 of them are still in service and require attention.

This is just the latest in problems for St. Jude Medical Inc as it courts acquisition by Abbot Laboratories. The battery issue with St. Jude defibrillators was known to Abbot prior to entering talks to purchase St. Jude in deal rumored to be worth some $25 billion. It is unclear whether the new pacemaker issue was also known or if it will come to a shock to Abbot analysts. Regardless, those that are invested in St. Jude Medical watched their shares shed another 1% of their value.