Model Number CI-1500-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Necrosis (1971); Necrosis Of Flap Tissue (1972); Skin Infection (4544)
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Event Type
Injury
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Event Description
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The recipient is experiencing skin flap necrosis with device extrusion.The infection was only partially controlled by systemic antibiotics.The infection is not believed to be device related.The recipient's device was explanted.The recipient was not reimplanted.
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Manufacturer Narrative
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The recipient's infection 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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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 array 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 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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