Medtronic Recalls 100,000 InSync III Pacemakers Due to Battery DefectDec 8, 2015
Medtronic recalled nearly 100,000 InSync III pacemakers due to a potential battery defect that could cause malfunction. Qmed reports that the U.S. Food and Drug Administration (FDA) has designated the recall as Class 2, meaning that exposure to the recalled product may lead to reversible adverse health effects or that there is a remote chance of serious health consequences. In an Urgent Medical Device Correction, Medtronic said it was aware of 30 cases affected by the battery issue. The company said there was a report one patient death where the faulty battery may have been a contributing factor.
The problem is that the battery may have unexpectedly high impedance, which may impair proper functioning if there is inadequate current. According to Qmed, the battery defect could lead to loss of pacing capture, erratic behavior, fluctuations in longevity estimates, and inaccurate lead impedances. More than 9,300 units in the United States are affected. A total of roughly 96,800 pacemakers were recalled. At least 22,000 patients worldwide have the pacemaker implanted.
In its letter to physicians, Medtronic said "it is not possible to identify which devices might fail or when they might fail. The issue cannot be mitigated by programming changes or increasing patient follow-up frequency."