Model Number CI-1601-05 |
Device Problems
No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Undesired Nerve Stimulation (1980); Pain (1994); Swelling/ Edema (4577)
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Event Date 09/01/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced pain and non auditory sensations with and without device use.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics device.
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Manufacturer Narrative
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The recipient reportedly presented with redness, inflammation, and swelling prior to revision surgery.The recipient's device activation reportedly went 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts in the silastic overmold on the bottom cover as well as cut electrode wires.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 version of the ultra device is no longer distributed.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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