Model Number CI-1600-04 |
Device Problems
Output below Specifications (3004); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 05/21/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Revision surgery is scheduled.
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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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The recipient's device was explanted.The recipient was reimplanted 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the array was severed prior to receipt, as well as tool damage to the top and bottom cover.All of these anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical tests performed.Advanced electrical testing performed on the device revealed 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 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 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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