Model Number CI-1601-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
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Patient Problems
Fluid Discharge (2686); Insufficient Information (4580)
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Event Date 02/14/2022 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing sound quality issues.A ct scan revealed correct device placement.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient will be re-implanted at a later date.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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The recipient is experiencing drainage and a thick tympanic membrane.The external visual inspection revealed damaged silicone overmold to the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the fantail and electrode ground ring.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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 has reportedly healed and there is no drainage or infection.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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