Model Number CI-1400-02H |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273); Intermittent Communication Failure (4038)
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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 12/06/2022 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing no sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.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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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 sliced silicone overmold on the top and bottom covers, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was obtained intermittently.The condition of the electrode prevented and electrical test from being performed.The device passed the electrical test performed.The residual gas analysis test exceeded the testing 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.An internal corrective action was implemented.Feedthru assemblies from this vendor are no longer used.This version of the hires 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.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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