Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage and torn silicone on the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires.System lock was verified.The device passed some of the electrical tests performed.The device failed residual gas analysis test.This device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feed-thru assemblies from this vendor are no longer used.In addition, x-ray inspection revealed broken wires in the fantail region.This version of the hires 90k device 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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