FDA issues Safety Alert for St Jude defibrillators

Editor's Note

The Food and Drug Administration on October 11 issued a Safety Alert for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St Jude Medical (Little Canada, Minnesota).

In some cases, full battery drainage can occur in a day to a few weeks after the patient receives an elective replacement indicator alert.

If the battery runs out, the defibrillator will be unable to deliver life-saving pacing or shocks, which could lead to patient death.

The defibrillators are powered with lithium-based batteries. Deposits of lithium can form in the battery and create abnormal electrical connections that lead to rapid battery failure.

In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.