Model Number E053 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) recorded an fc 1003 indicative of battery voltage too low for the projected remaining capacity and observed that the battery was inaccurate.Boston scientific technical services (ts) discussed that this device was not on the low voltage capacitor advisory, however, similar failure rates were noted.Ts also discussed that without analysis an emergent changeout is recommended per faults and actions.A device data for analysis was advised which could give cause and guidance for change out timing.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.The returned implantable cardioverter defibrillator (icd) was analyzed and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded.The battery voltage was lower than expected, but still supported full device function.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) recorded an fc 1003 indicative of battery voltage too low for the projected remaining capacity and observed that the battery was inaccurate.Boston scientific technical services (ts) discussed that this device was not on the low voltage capacitor advisory, however, similar failure rates were noted.Ts also discussed that without analysis an emergent changeout is recommended per faults and actions.A device data for analysis was advised which could give cause and guidance for changeout timing.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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