Model Number E140 |
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 07/07/2022 |
Event Type
Injury
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirm low voltage fault and that the power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator atmosphere.Device replacement or reassess device within 90 days was recommended.To date, the device remains in service.No 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.
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirm low voltage fault and that the power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator atmosphere.Device replacement or reassess device within 90 days was recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that the device was explanted.A new device was implanted.No additional adverse patient effects were reported.
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Event Description
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It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirm low voltage fault and that the power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pulse generator atmosphere.Device replacement or reassess device within 90 days was recommended.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that the device was explanted.A new device was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.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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Search Alerts/Recalls
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