Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 10/01/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.A review of the recipient¿s test data indicated impedance issues.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 implant.
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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 the electrode was cut 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 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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