Nearly 100,000 Medtronic Pacemakers Recalled Due to Battery Defect

Due to a potential battery defect that could lead to malfunction, Medtronic recalled nearly 100,000 InSync III pacemakers. The recall has been designated as Class 2 by the U.S. Food and Drug Administration (FDA). Class 2 recalls are for products that may lead to reversible adverse health effects or have a remote chance of serious health consequences or death.

Medtronic issued an Urgent Medical Device Correction to doctors, stating that it was aware of 30 cases affected by the battery issue. 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.”

There was a report of one patient death where the faulty battery may have been a contributing factor, Medtronic said. The recall was issued because the battery may have an 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.

from Parker Waichman http://www.yourlawyer.com/blog/nearly-100000-medtronic-pacemakers-recalled-due-to-battery-defect/