Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 12/17/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing impedance issues and decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient's 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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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 cuts to the top and bottom covers and electrode.Able to see cut wires in electrode between fantail and electrode ground ring.Electrode ground ring has been displaced.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut wires in electrode between fantail and electrode ground ring.The photographic imaging inspection revealed an electrode was broken within the electrode pocket.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical test 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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Search Alerts/Recalls
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