St. Jude Medical Inc. has issued a warning about battery problems in some defibrillators made before May 2015.
Defibrillators deliver powerful electric shocks to restore normal heart-rhythm. Failure to deliver a shock can lead to severe injuries or death.
Two patients died when their defibrillator ran out of batteries and did not deliver an electric shock in an emergency. Another 47 patients reported dizziness or fainting due to the problem.
Patients should respond immediately if their defibrillator produces an alert indicating low battery. Full battery drainage can occur within 24 hours to a few weeks, according to the FDA.
St. Jude said 841 defibrillators were returned due to premature battery depletion. It blamed the problem on “lithium clusters” accumulating in the battery, creating a short-circuit that rapidly depletes the battery.
The “lithium cluster” defect was reported nearly two years ago — 39 cases of premature battery failure from 2010-2013 were associated with the St. Jude Fortify and Unify defibrillators. Findings were published by the journal Heart Rhythm in December 2014.
St. Jude has recalled the following ICD and CRT-D model defibrillators manufactured before May 23, 2015:
- Fortify VR
- Fortify ST VR
- Fortify Assura VR
- Fortify Assura ST VR
- Fortify DR
- Fortify ST DR
- Fortify Assura DR
- Fortify Assura ST DR
- Unify Quadra
- Unify Assura
- Quadra Assura
- Quadra Assura MP
Source: FDA Safety Communication