Model Number CI-1500-02H |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 01/19/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced decreased performance and open circuits.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 cuts in the bottom cover overmold and along the electrode.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the electrode ground ring.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The photographic imaging inspection revealed broken wires near the electrode ground ring.It is believed that these breaks caused the open circuits reported.A corrective action was implemented.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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Search Alerts/Recalls
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