Model Number CI-1601-05 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2019 |
Event Type
malfunction
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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 is scheduled.
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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 damage on the top and bottom covers, and the electrode was sliced along the lead prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires at the fantail.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical test performed.The scanning electron microscopy analysis confirmed tensile breaks at some electrode wires within the fantail.The photographic imaging inspection and scanning electron microscopy analysis revealed broken wires in the fantail region.It is believed that these breaks caused the open impedances recorded.Advanced bionics will continue to monitor for failure modes of this type and will implement corrective actions as necessary.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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The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics device.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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