Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004)
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Patient Problem
No Information (3190)
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Event Date 06/07/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: section d.7.Advanced bionics considers the investigation into this reportable event as closed.The recipient's device will reportedly not be explanted at this time.No further details will be provided.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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Manufacturer Narrative
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A review of the recipient¿s test data indicated impedance issues.The recipient is pursuing revision surgery.Revision surgery is scheduled.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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The recipient's device was 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 in the silastic overmold on the top cover and bottom cover.In addition, the electrode was severed.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.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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