The recipient reportedly experienced decreased performance and sound quality issues.Programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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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 severed near the fantail prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.Advanced electrical testing performed on the device showed 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 can be attributed to electrode shorts in the electrode pocket of the device.A corrective action was initiated.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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