Model Number E160 |
Device Problems
Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.In addition, device current battery longevity estimate is not accurate.Data analysis confirmed low voltage fault and that the device was malfunctioning.Device replacement was then suggested.To date, no intervention was performed and device remains in service.No 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.
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Event Description
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It was reported that the device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.In addition, device current battery longevity estimate is not accurate.Data analysis confirmed low voltage fault and that the device was malfunctioning.Device replacement was then suggested.Additional information indicated that the device was explanted.No additional adverse patient effects were reported.No adverse patient effects were reported.
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Event Description
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It was reported that the device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.In addition, device current battery longevity estimate is not accurate.Data analysis confirmed low voltage fault and that the device was malfunctioning.Device replacement was then suggested.To date, no intervention was performed and device remains in service.No adverse patient effects were reported.Additional information indicated that the device was explanted.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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Search Alerts/Recalls
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