Model Number SONATA |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
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Event Description
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The device was received at headquarters by the investigation team.Per device explantation report form (derf) the device has contributed to re-implantation.
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Manufacturer Narrative
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Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The damage found appears to be consistent with the limited available information.This is a final report.
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Event Description
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The device was received at headquarters by the investigation team.Per device explantation report form (derf) the device has contributed to re-implantation.Despite requested, no additional information could be retrieved.
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Search Alerts/Recalls
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