Implanted defibrillators (ICDs and CRT-Ds) are powered by lithium-based batteries. Deposits of lithium, known as “lithium clusters,” can form within the battery and create abnormal electrical connections leading to rapid battery failure. St. Jude Medical has initiated a recall and correction of the affected devices, as well as sent out a letter to doctors.
St. Jude Medical, stock symbol STJ, has reported that in some cases, full battery drainage can occur within a day to a few weeks after the patient receives an ERI alert. If the battery runs out, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.
To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters.
- 2 deaths (1 in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion.
For more information about these types of claims, see Product Liability.
For more information about this topic, see: St. Jude's Website