Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Energy Output Problem (1431); Intermittent Communication Failure (4038)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient was reportedly experiencing intermittencies and overly loud sound.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The recipient has been activated and the issue has resolved.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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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.The device passed photographic imaging inspection.System lock was obtained intermittently.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed some of the mechanical tests performed.The residual gas analysis test exceeded the test limit.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issues from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.This version of the hi res 90k 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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