Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the array was severed prior to receipt, as well as sliced silicone over mold damage to the top cover.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires near the fantail region.This is believed to have occurred during revision surgery.System lock was verified.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis of the electrode pocket revealed corrosion on some electrodes.This is due to the presence of moisture residing within the electrode pocket, which can be attributed to electrode shorts.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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