Model Number CI-1601-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Skin Disorders (4543)
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Event Date 10/26/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced a cholesteatoma and inflammation.The recipient's device was explanted.The recipient has recovered.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.No additional treatment details will be provided.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was explanted due infection and biofilm on implant.The recipient has reportedly recovered.No additional treatment details will be provided.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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