Model Number CI-1400-01 |
Device Problems
Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Damage (2104); Tissue Breakdown (2681)
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Event Date 12/21/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a wound on the skin above the implant.The recipient lost weight and area was prone to friction due to the device position.No medical intervention or hospitalization was required prior to explantation.The recipient's device was explanted to help the wound heal.The issue is not believed to be device related.The recipient is in the process of healing and reimplantation is under consideration.
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Manufacturer Narrative
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The recipient reportedly experienced device extrusion prior to explant 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's wound and medical issues reportedly 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.The external visual inspection revealed 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 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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