Model Number CI-1500-04 |
Device Problems
No Audible Prompt/Feedback (2282); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Burning Sensation (2146); Discomfort (2330)
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Event Date 12/10/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing pain and non-auditory sensations.The recipient is a non user due to reported intermittent burning and tenderness with and without device use.Device testing could not be completed due to recipient discomfort.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: sections b.3 & d.6b.The recipient's device was explanted.The recipient will reportedly remain a non-user on that side.The recipient has healed.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 tool damage to the top and bottom covers.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 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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