Model Number CI-1400-01 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Information (3190)
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Event Date 10/10/2019 |
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 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 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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The external visual inspection revealed that the electrode was severed 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 some of the electrical tests from being performed.The device passed an electrical test performed.This is an interim 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed 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 and the electrode condition prevented some electrical tests 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.Leak testing did not reveal any leaks.Corrective actions were implemented.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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