Model Number CI-1601-04 |
Device Problems
Energy Output Problem (1431); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
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Event Date 04/14/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced pain, non auditory sensations, and decreased performance.The recipients device was explanted to control allergies and was swabbed for infection.The recipient was not reimplanted at this time.
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Manufacturer Narrative
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The recipient's pain was reportedly not resolved with surgery.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 reportedly had a bacteriological analysis that confirmed a germ.The recipient's pain reportedly increased after the bacteriological analysis.The recipient reportedly had an mri that confirmed an atypical lesion.Test's are being performed to determine the origin of the lesion.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 reportedly experiencing an infection on the auditory nerve.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 will not be re-implanted.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 root cause cannot be determined as it could involve: recipient anatomy/ hygiene, cochlear environment, surgical technique, trauma to the recipient, etc.Advanced bionics cannot obtain anymore information due to patient privacy laws.The external visual inspection revealed cuts in the silicone overmold on the top cover, as well as a severed electrode.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode 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.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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