Model Number CI-1600-04 |
Device Problems
Device Slipped (1584); Appropriate Term/Code Not Available (3191); Intermittent Communication Failure (4038)
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Patient Problem
No Information (3190)
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Event Date 11/12/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing intermittent lock.External equipment was exchanged and 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top and bottom covers, near the electrode ground ring, and near the antenna prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.The reported complaint of no-lock without physical pressure applied to the headpiece could not be verified during this analysis.The device passed the electrical tests performed.No corrective action is indicated.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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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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