Model Number CI-1400-01 |
Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/16/2022 |
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 patient is reportedly experiencing a middle ear infection and is a non-user.Radiological investigation revealed bilateral cochlear dysplasia and deformed modiolus.Scanning indicates no sign of migration.Explant surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient's infection resolved and is doing well.Reimplantation may be considered 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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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 external visual inspection revealed cuts in the silicone overmold on the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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