Model Number CI-1500-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Necrosis Of Flap Tissue (1972); Swelling (2091); Swelling/ Edema (4577)
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Event Date 06/23/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing skin flap necrosis behind the incision site.The recipient presented with swelling.The recipient's device was explanted.The recipient will not be implanted at this time.
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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 external visual inspection the revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.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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The recipient has reportedly healed.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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