Model Number CI-1400-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Purulent Discharge (1812); Failure of Implant (1924); Inflammation (1932); Ulceration (2116); Ulcer (2274); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced a skin ulcer behind the ear with partial obstruction of the device and electrode extrusion.The recipient was presenting with purulent secretions and inflammation at the implant site about two months ago.On (b)(6) 2020 the recipient's device was explanted.The recipient has healed well and will be reimplanted.
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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 a cut in the silicone on the bottom cover.In addition, 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 device passed the electrical tests performed.The device passed the mechanical test 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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