Model Number CI-1601-05 |
Device Problems
Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing no sound due to an anatomy issue.The surgeon confirmed there is a disconnect between the nerve and cochlea.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: sections b.3 & d.6b.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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The recipient's device was reportedly explanted.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 electrode wires were cut near the array prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires near the array.This is believed to have occurred during revision surgery.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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