Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis identified a high current drain was a result of compromised capacitors, which resulted in 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 in september 2018, which was expanded in june 2021, regarding a subset of devices in the accolade pacemaker family that has an elevated potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.
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