Model Number L231 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2022 |
Event Type
Injury
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Event Description
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It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.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.The plan is to monitor and evaluate the battery status later on in order to postpone the replacement procedure as long as possible.This device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was requested.The investigation will be updated should further information be provided.
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Manufacturer Narrative
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Additional information was requested.The investigation will be updated should further information be provided.
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Event Description
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It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.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.The plan is to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.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.The plan was to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device was replaced and returned for analysis.No additional adverse patient effects were reported.Customer comment: the physician requested the possibility to have battery details printed from the programmer as well as a shortcut on remote monitoring to view battery details.Also, requested to have an alert when high, abnormal energy drain is detected.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.Additional information was requested.The investigation will be updated should further information be provided.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.Additional information was requested.The investigation will be updated should further information be provided.Follow up report 3: 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 the battery of this implantable device was suspected to be depleting prematurely during routine follow up.The power consumption was higher than expected.The estimated longevity decreased from ten and a half years to six years within an eight month period.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.The plan was to monitor and evaluate the battery status every three months in order to postpone the replacement procedure as long as possible.This device was replaced and returned for analysis.No additional adverse patient effects were reported.Customer comment: the physician requested the possibility to have battery details printed from the programmer as well as a shortcut on remote monitoring to view battery details.Also, requested to have an alert when high, abnormal energy drain is detected.
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Search Alerts/Recalls
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