Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/07/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance and sound quality issues.A review of the recipient¿s test data indicated impedance issues.Revision surgery is scheduled.
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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 silicone on the bottom cover, and the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The device passed an electrical test performed.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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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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Search Alerts/Recalls
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