Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
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Patient Problems
Therapeutic Response, Decreased (2271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/16/2023 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Revision surgery will be scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly been lost to follow up.The recipient remains implanted.Further information will not be provided.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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The recipient's device was explanted.The recipient was reimplanted 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 the electrode was severed.This is believed to have occurred during revision surgery.Photographic imaging inspection revealed broken electrodes within the electrode pocket.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires 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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