Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top cover and along the lead prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed some electrode wires were broken within the electrode pocket.In addition, broken wires were observed along the lead and near the array, which are believed to have occurred during revision surgery.System lock was verified.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 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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