Model Number CI-1601-05 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/04/2022 |
Event Type
malfunction
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Event Description
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The recipient reportedly underwent revision surgery for electrode extrusion.During revision surgery a review of the rest data indicated impedance issues.The recipient 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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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 to the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests 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 hires 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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