Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004)
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Patient Problem
No Information (3190)
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Event Date 11/18/2020 |
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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The recipient's device was reportedly explanted.The recipient was reimplanted with another 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.Due diligence attempts to obtain additional details regarding possible revision surgery were unsuccessful.No further details will 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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Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual and photographic imaging inspections.System lock was verified.The device passed the electrical tests performed.The scanning electron microscopy (sem) analysis revealed corrosion on some electrodes.The device passed the mechanical test 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 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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