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Model Number CI-1400-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/07/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device extrusion.The recipient reportedly had skin flap revision surgery in (b)(6) 2021, which seemed to resolve the issue, however, after a month the device began to extrude.The recipient's device was reportedly explanted.The recipient was implanted on the contra-lateral side with another advanced bionics cochlear device.
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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 recipient has reportedly recovered.No further treatment details will be provided.The external visual inspection revealed cuts in the silastic overmold on the top cover, bottom cover and the fantail region.In addition, the electrode was severed.This is believed to have occurred during revision surgery.The device passed 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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Search Alerts/Recalls
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