Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
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It was reported that this pacemaker device data was not able to upload.There were no reports available for boston scientific technical services (ts) to review.Ts discussed that device was likely at elective replacement indicator (eri) and instructed health care professional to re-interrogate device and retry to read and send data however, if data not uploaded, ts recommended a review using programmer.Additional information was received indicating that this device was electively explanted due to normal battery depletion (nbd) and a new device was placed.No adverse patient effects reported.
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