Model Number G247 |
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 06/27/2022 |
Event Type
Injury
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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.Boston scientific technical services (ts) discussed that message indicates prematurely depleting and need data to analyze.Ts also recommended replacement regardless of the data.Additional information was received indicating that the device was explanted due to premature battery depletion (pbd).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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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.Boston scientific technical services (ts) discussed that message indicates prematurely depleting and need data to analyze.Ts also recommended replacement regardless of the data.Additional information was received indicating that the device was explanted due to premature battery depletion (pbd).No additional adverse patient effects were reported.
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Search Alerts/Recalls
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