Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); No Audible Prompt/Feedback (2282); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/04/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing no sound to stimulation and electrode extrusion.The recipient has had a mastoidectomy and noted that sound ceased after scratching the ear canal.Programming adjustments were made, however, the issue did not resolve.The extruding portion of the device was removed.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient is healing 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 the electrode was severed prior to receipt.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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