Model Number CI-1601-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Complaint, Ill-Defined (2331); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly a poor performer.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted with another advanced bionics cochlear device.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 damaged silicone on the top and bottom covers, and the electrode was sliced near the electrode ground ring prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires near the electrode ground ring.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.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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