Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Failure of Implant (1924); Therapeutic Response, Decreased (2271)
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Event Date 02/17/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted 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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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 that the electrode was severed prior to receipt, as well as sliced silicone overmold to the top and bottom covers and near the fantail region.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection revealed that an electrode was severely corroded within the electrode pocket.System lock was verified.The device passed some of the electrical tests performed.The scanning electron microscopy (sem) analysis revealed corrosion on some electrode wires.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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