Model Number L301 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
Injury
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Event Description
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It was reported that there were concerns of premature battery depletion for this pacemaker as it reached elective replacement indicator.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.The device remains in service and there is no evidence to suggest a device replacement procedure has been scheduled at this time.No 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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Event Description
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It was reported that there were concerns of premature battery depletion for this pacemaker as it reached elective replacement indicator.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.Additional information was received confirming the explant of this device.No adverse patient effects were reported.
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Event Description
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It was reported that there were concerns of premature battery depletion for this pacemaker as it reached elective replacement indicator.A request was made to have data from this device analyzed.The data analysis noted the battery appeared to be depleting more quickly than expected.A device replacement was recommended.Additional information was received confirming the explant of this device.No adverse patient effects were reported.
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Search Alerts/Recalls
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