Model Number CI-1400-01 |
Device Problems
Fracture (1260); Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Discharge (2225); Fluid Discharge (2686); No Code Available (3191); Skin Infection (4544); Swelling/ Edema (4577)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced an infection.The recipient presented with inflammation and discharge at the incision site.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics device in the contralateral ear.
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Manufacturer Narrative
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The recipient's infection is reportedly not device related.The recipient presented with swelling of the skin flap and device extrusion with loss of skin.The recipient is doing 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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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 cuts in the silicone on the top and bottom covers, the electrode ground ring was loose, and the electrode was severed prior to receipt.These are 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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