Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Appropriate Term/Code Not Available (3191)
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Patient Problem
Failure of Implant (1924)
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Event Date 03/17/2021 |
Event Type
malfunction
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Event Description
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A review of the recipient¿s test data indicated impedance issues.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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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 sliced silicone overmold and tool damage to the top and bottom covers.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed an electrode was severely corroded within the electrode pocket.System lock was verified.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode pocket revealed corrosion of electrode wires.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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