Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 03/12/2021 |
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.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was reimplanted 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed damaged silicone on the top and bottom covers, and the electrode was severed near the electrode ground ring and array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed some of the electrical tests 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 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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