On October 11, 2016, the FDA and St. Jude Medical alerted patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts from Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) made by St. Jude Medical. Due to problems with these batteries, patients do not have the normal 3-month lead time for device replacement. Some batteries have run out within 24 hours of the patient receiving an ERI alert.
St. Jude Medical has initiated a recall and correction of the affected devices and 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.
Battery depletion may not always be reported to the manufacturer, therefore the true number of devices with premature battery depletion due to lithium clusters is not known. To date, of the 398,740 affected devices sold worldwide, 841 were returned for analysis due to premature battery depletion caused by lithium clusters. Two deaths (one in the U.S.), have been associated with devices that could not provide needed shock therapy due to premature battery depletion. Ten patients (nine in the U.S.), have reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion. Thirty seven patients (thirty in the U.S.), have reported dizziness from devices that could not provide needed pacing therapy due to premature battery depletion.
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. Premature battery depletion due to lithium clusters has only been observed in devices manufactured prior to May 2015. At this time, there is no information indicating that this issue affects devices manufactured after this date.
See the FDA Safety Alert
See the FDA Safety Communication
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues