Model Number MI1200 SYNCHRONY |
Device Problem
Output Problem (3005)
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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 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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At a rehabilitation check up affected channels were seen.It was reported that the user fell on their forehead.The user will be re-implanted.
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Event Description
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At a rehabilitation check-up affected channels were seen.It was reported that the user fell on his forehead on the (b)(6) 2020.The user has been re-implanted.
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Manufacturer Narrative
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Conclusion: the investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
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Search Alerts/Recalls
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