Manufacturing defects continue to cause distress for Medtronic, with a new US Food and Drug Administration (FDA) safety communication warning of premature battery depletion in pacemakers.
The agency’s safety notice alerted about an issue with device capacitors, which led to rapid battery depletion in certain Medtronic implantable pacemaker models. It indicated FDA’s awareness of three adverse event reports linked to this issue—one of which resulted in the death.
“In the three complaints, the devices unexpectedly lost device function after experiencing rapid battery depletion due to a ceramic capacitor leakage pathway,” Kathleen Janasz, director of communications at Medtronic Cardiac Rhythm and Heart Failure (CRHF), told Focus
. Janasz added that two patients were affected by the issue “as one device was identified while still packaged and prior to implant,” whereas the other two adverse events “occurred at five and nine months after [pacemakers] were implanted.”
Potentially affected devices include twelve models in the Azure and Astra suite and twelve additional models of the Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P) suite.
Minneapolis-based Medtronic has seen greater FDA oversight in recent years, following the 2017 hurricanes that struck its operations in Puerto Rico. It drew
two FDA warning letters last September—one to CRHF in Minnesota and one to the Medtronic Puerto Rico Operations Company—after 2018 site visits to both manufacturing plants revealed violations of good manufacturing practices. The warning letters spoke to an earlier Class I recall
of certain Medtronic implantable cardiac defibrillator models.
Medtronic cardiac devices, programmers and home monitors were also subject
to a March FDA safety communication and an ICS-CERT advisory due to cybersecurity vulnerabilities in telemetry protocol.
FDA’s database of adverse event reports describes issues with using Medtronic’s programmers as well. A Solara CRT-P “was unable to be interrogated using multiple programmers,” according to a November 2018 report
. The returned device “indicated leakage in the hybrid” and a hybrid analysis “determined that the anomalous current drain was due to a faulty c12 capacitor,” Medtronic reported. The three adverse event reports point to manufacturing plants in Minnesota, Puerto Rico and Switzerland.
FDA and Medtronic, however, expect low rates of early battery depletion with the devices affected by the 7 May safety communication and do not recommend preventive device removal and replacement.
The projected rate of occurrence with the pacemaker battery problem is 0.0028%, according to the new performance note
. “Based on the low predicated rate of failure, we expect few, if any, additional events to occur,” Janasz said. About 266,700 devices have been distributed worldwide since February 2017.
The agency also said
it has approved “a new step in Medtronic’s manufacturing process developed to better detect capacitor failures in newly manufactured devices” and the device maker’s “use of a different capacitor in newly manufactured devices to reduce the risk of premature battery depletion.”