Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Undesired Nerve Stimulation (1980); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing bilateral endolymphatic hydrops and facial nerve stimulation (fns).The recipient was prescribed hydrochlorothiazide 12.5 mg once day.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.Due diligence attempts to obtain additional information regarding treatment details and recipient status were unsuccessful.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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