Model Number 429523 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The available data were thoroughly inspected.Analysis of the data revealed a prolonged charge time as mentioned in the complaint description.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component.Should the device become available for analysis, this investigation will be updated.
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Event Description
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Charge time is rapidly increasing indicating a possible battery issue.No adverse patient events were reported.Device remains implanted.Should additional information be received, this file will be updated.
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Manufacturer Narrative
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The device was explanted on (b)(6) 2024.The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The available data were thoroughly inspected.Analysis of the data revealed a prolonged charge time as mentioned in the complaint description.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component.Should the device become available for analysis, this investigation will be updated.
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Search Alerts/Recalls
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