Model Number CI-1600-05 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Output below Specifications (3004)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 03/03/2021 |
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.Programming adjustments were made.Revision surgery is under consideration.
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Manufacturer Narrative
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The recipient 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed sliced silicone overmold on the top and bottom covers near the fantail region.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed an electrode was broken within the electrode pocket.In additional, the photographic imaging inspection revealed a broken electrode wire in the array region.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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