St. Jude Medical Recalls Battery for Heart Devices Following 2 Patient DeathsOct 13, 2016
St. Jude Medical is recalling batteries used in its Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) heart devices. The recall is being issued due to early battery failure, which has been linked two patient deaths. The devices are used to deliver an electrical shock to patients with a dangerously fast heart rhythm, or provide pacing for patients with a slow heart rhythm.
Nearly 400,000 devices are implanted worldwide; 841 have been returned to St. Jude due to battery failure. There were two cases where patients died because the battery was unable to administer a life-saving shock. Other adverse events were reported as well. Ten patients fainted and 37 experienced dizziness because the battery lacked enough power to provide therapy. According to a safety alert posted on the FDA website, the actual number of reports may be higher because problems are not always reported to the manufacturer.
The early failure is caused by "lithium clusters", where deposits of lithium form within the batteries and disrupt electrical connections. When lithium clusters occur, they can cause the battery to drain quickly. As such, patients and caregivers are urged to respond to the Elective Replacement Indicator (ERI) as soon as it goes off. There is normally a three-month period after the ERI alert where the battery can be replaced, but St. Jude has received reports where the battery fully drained with a day or few weeks.
If the battery is drained, then it will be unable to administer a life-saving shock when needed. The alert notes that "The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent."
The following ICD and CRT-D models manufactured before May 2015 are affected, according to the FDA alert:
- 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