ST. PAUl, Minn. (KMSP) - St. Jude Medical announced Tuesday that the lithium batteries in nearly 350,000 implanted defibrillators are at risk of running out earlier than expected, which could cause the device to fail. Two deaths have been reported.
Patients normally get a vibrating alert -- an Elective Replacement Indicator (ERI) -- 3 months before the battery will run out, but some batteries have run out within 24 hours of the patient receiving the alert.
“St. Jude Medical 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,” said an FDA announcement. “The patients most at risk are those with a high likelihood of requiring life-saving shocks and those who are pacemaker dependent.”
Premature battery depletion can also be detected during doctor office visits and through remote monitoring.
St. Jude has asked doctors to contact their patients with information about the battery problem. The company says a replacement of the device is not recommended unless the doctor determines otherwise. If a replacement is recommended, St. Jude will provide a replacement device at no cost.
This advisory affects St. Jude Medical’s ICD and CRT-D devices manufactured before May 23, 2015.
“While it is a rare occurrence (0.21 percent), we want to ensure we are providing the information physicians need to best care for their patients,” St. Jude Medical said in an advisory.
St. Jude traced the battery problem to deposits of lithium, known as “lithium clusters,” that can form within the battery and cause it to short-circuit. St. Jude has confirmed premature battery depletion in 841 of its 398,740 implanted devices, including 549 patients in the United States. Of those 841 defective devices, 46 had visible evidence of lithium clusters.
St. Jude has a website with answers to common questions at www.sjm.com/batteryadvisory.