Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Intermittent Communication Failure (4038)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/17/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: section d.7.The recipient's device was reportedly 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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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 tool damage to the bottom cover, as well as cuts to the electrode in the straight portion and also near the array prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.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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