Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the top cover, and the electrode was severed at the fantail and near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.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 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.
|