Model Number CI-1500-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problem
Unspecified Infection (1930)
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Event Date 08/22/2022 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a skin flap infection at the implant site and device extrusion.The recipient's device was explanted.The recipient will be reimplanted at a later time.
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Manufacturer Narrative
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The recipient is reportedly healing well.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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A device history review was requested by the nca and no anomalies were noted.The recipient has reportedly recovered.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 a severed electrode.This is 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 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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