Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
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Patient Problem
Nerve Damage (1979)
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Event Date 10/22/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing loss of sound due to a cochlear nerve insufficiency.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient reportedly experienced no progress with device and has a small internal auditory canal.The recipient's device was 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 recipient's device will reportedly not be explanted a this time.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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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 tests performed.Advanced electrical testing performed on the device showed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The device passed the mechanical test performed.This device was explanted for medical reasons.However, this device had an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra 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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