Model Number E140 |
Device Problems
Premature Discharge of Battery (1057); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2022 |
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 implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault and found that the power consumption was increasing gradually and appeared to be consistent with the capacitor degradation due to hydrogen gas content.Recommended device replacement or re-assessed within ninety days window.To date, the 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 implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault and found that the power consumption was increasing gradually and appeared to be consistent with the capacitor degradation due to hydrogen gas content.Recommended device replacement or re-assessed within ninety days window.To date, the device remains in service.No adverse patient effects were reported.Additional information received indicating that the device was beeping.
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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 implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault and found that the power consumption was increasing gradually and appeared to be consistent with the capacitor degradation due to hydrogen gas content.Recommended device replacement or re-assessed within ninety days window.To date, the device remains in service.No adverse patient effects were reported.Additional information received indicating that the device was beeping.Subsequently, this device was explanted and replaced without difficulty.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.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 device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 1003) was recorded.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 low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.
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Event Description
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It was reported that the implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault and found that the power consumption was increasing gradually and appeared to be consistent with the capacitor degradation due to hydrogen gas content.Recommended device replacement or re-assessed within ninety days window.To date, the device remains in service.No adverse patient effects were reported.Additional information received indicating that the device was beeping.Subsequently, this device was explanted and replaced without difficulty.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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