Model Number CI-1400-02H |
Device Problems
Device Slipped (1584); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 02/18/2020 |
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 is scheduled.
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Manufacturer Narrative
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The recipient's device was 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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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 photographic imaging inspection confirmed severed electrode wires.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The no lock 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.Based on an assessment of the residual gas analysis test data, it is believed that this device was not hermetic.This ultimately caused the device to cease functioning.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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