Model Number CI-1600-04 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 02/19/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top and bottom covers prior to receipt.These are believed to have occurred during revision surgery.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 tests performed.Advanced electrical testing performed on the device showed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was initiated.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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