Model Number CI-1500-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Date 11/12/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device rejection due to an allergic reaction.The recipient presented with skin flap redness and swelling for two months.The recipient's device was explanted.The surgeon found no sign of infection during surgery.The recipient will be reimplanted.The recipient has recovered well.
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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 on the top cover and also in the fantail.Additionally, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.The device passed the mechanical test 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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