Product News and Recalls

St. Jude Defibrillator Patients Warned Over Battery Issues

heart defibrillator patients warned of battery problemsCell phone owners are all-too-familiar with the curse of a rapidly depleting battery. An app grabs on to the processor and sends battery usage through the roof, and the battery you thought was at 75% is actually at 15%. It’s only 1:00 in the afternoon and you’re already reaching for a charger.

Now imagine the horror of that scenario playing out in your chest with your defibrillator.

As terrifying as that sounds, that is exactly what is happening to patients implanted with defibrillators manufactured by St. Jude Medical Inc. (not to be confused with St. Jude Children’s Research Hospital; an entirely different entity). The publicly traded company sent letters to doctors and patients this month warning them of a defect in which a defibrillator battery can discharge to the point of being unable to shock the patient’s heart back to a normal rhythm should the need arise.

Two deaths have already been reported because of the failure, as have 47 reports of dizziness or fainting.

Currently, only units manufactured prior to May 2015 are affected. This, however, represents approximately 350,000 people around the world. Company Chief Medical Officer Mark Carlson says that remote monitoring is advised so that patients’ physicians can check on the devices and determine if further action is needed.

The issue comes amid a bit of flux for St. Jude Medical, as the company is in talks to be acquired by Abbot Laboratories. Negotiations are expected to be completed by the end of this year in a deal worth approximately $25 billion. At the same time, reports of potential security vulnerabilities surfaced alleging that St. Jude defibrillators were vulnerable to hacking. That allegation, however, was brought up by a short-seller of St. Jude stock, raising questions as to the motive of such a report as well as its timing and accuracy.

Still, the effects of the claims and defect have been notable. Both Abbot and St. Jude stock dropped on the news and the FDA cautioned on the use of St. Jude Medical defibrillators. The agency called for the immediate replacement of any St. Jude defibrillator that showed signs of battery depletion and advised against the use of any implant made by the company prior to May of 2015. Experts also continue to analyze and investigate the defibrillator’s vulnerability to hacking.