Model Number L311 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
Malaise (2359)
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Event Date 05/05/2022 |
Event Type
Injury
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Event Description
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It was reported that the pacemaker was explanted due to concerns of premature battery depletion (pbd).The device switched to a predetermined pacing mode as a result of the extremely low remaining battery capacity, which is an expected behavior.It was noted that the patient reported feeling unwell due to the lack of atrial-ventricle (av) synchrony in the predetermined pacing mode.The device was explanted and replaced.No additional adverse patient effects were reported.
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Event Description
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It was reported that the pacemaker was explanted due to concerns of premature battery depletion (pbd).The device switched to a predetermined pacing mode as a result of the extremely low remaining battery capacity, which is an expected behavior.It was noted that the patient reported feeling unwell due to the lack of atrial-ventricle (av) synchrony in the predetermined pacing mode.The device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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