Model Number CI-1400-02H |
Device Problem
Program or Algorithm Execution Problem (4033)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/08/2019 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing an abnormal electrode.Programming adjustments and deactivation of some electrodes were performed, however, the issues 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.
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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 external visual inspection revealed silicone damage on the top cover, a slice on the fantail, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the fantail.System lock was verified.The electrode condition prevented some of the electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode confirmed fatigue breaks at the fantail.The photographic imaging inspection revealed broken wires in the fantail region.It is believed that these breaks caused the open circuits reported.A corrective action was 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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Event Description
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The recipient is reportedly experiencing open electrodes.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Search Alerts/Recalls
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