Model Number L231 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
Anxiety (2328)
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Event Date 07/20/2021 |
Event Type
Injury
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Event Description
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It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended, however this pacemaker remains in-service at this time.The patient was reported to have anxiety related to the pending replacement procedure.No intervention required for the anxiety.No additional adverse patient effects were reported.
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Event Description
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It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended, however this pacemaker remains in-service at this time.The patient was reported to have anxiety related to the pending replacement procedure.No intervention required for the anxiety.No additional adverse patient effects were reported.Additional information was received.This pacemaker was successfully replaced and is expected to be returned to boston scientific for analysis.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 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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Event Description
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It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended, however this pacemaker remains in-service at this time.The patient was reported to have anxiety related to the pending replacement procedure.No intervention required for the anxiety.No additional adverse patient effects were reported.Additional information was received.This pacemaker was successfully replaced and is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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