Model Number CI-1600-04 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Information (3190)
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Event Date 06/18/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.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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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 silicone damage on the top and bottom covers, and damage along the lead prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrodes within the electrode pocket.In addition, broken wires were observed near the fantail and damaged wires along the lead, which are believed to have occurred during revision surgery.System lock was verified.The device passed the electrical test performed.Advanced electrical testing performed on the device revealed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra is no longer distributed.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 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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Search Alerts/Recalls
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