Model Number CI-1600-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Discharge (2225)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced a skin infection.The recipient was prescribed antibiotics which helped.However, a sore was recurring due to wearing glasses.The recipient presented with discharge and an infection behind the tympani membrane.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The recipient's infection has resolved.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 treatment details will not be provided.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.The external visual inspection revealed silicone slices on the top cover, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.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.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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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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Search Alerts/Recalls
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