Model Number CI-1601-05 |
Device Problem
Expulsion (2933)
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Patient Problems
Wound Dehiscence (1154); Erosion (1750); Unspecified Infection (1930)
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Event Date 04/14/2023 |
Event Type
Injury
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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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Event Description
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The recipient is reportedly experiencing skin dehiscence and device extrusion.Revision surgery is scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's wound has healed and the infection has resolved.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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The recipient reportedly presented with a thin skin infection.The recipient's device was explanted.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.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the 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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