Model Number CI-1601-05 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient is presenting with loss of sound, despite device testing within normal limits.Revision surgery is scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will not pursue revision surgery at this time.The recipient is wearing the device and will be monitored by the facility.No further treatment details were provided.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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