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 Date 12/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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Device malfunction.No trauma has been reported.
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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 problems given in the recipient report appear to match the damage found.This is a final report.
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Event Description
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Device malfunction.No report of trauma has been received.The recipient has been re-implanted.
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Search Alerts/Recalls
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