Initially, it was reported that the patient was experienced spasms and pain at the generator site with device stimulation on time.It was reported that device diagnostics were within normal limits (dc dc code - 2).It was reported that the pain and discomfort had been present for a few days.Device settings were adjusted.It was later reported that the patient and discomfort were not any better with a decrease in device settings and frequency, so the patient was referred for surgery.The device was programmed off pending the surgery.There were no changes in medications or trauma or falls that may have caused or contributed to the pain and discomfort.The patient underwent surgery for patient comfort.The surgeon identified a break in the outer lead tubing in two places therefore, the patient underwent generator and lead replacement.Device diagnostics with the new vns system were within normal limits.The lead and generator were received for analysis.Analysis is underway, but has not been completed to date.
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Analysis was completed for the generator on 04/23/2015.The generator performed according to functional specifications, and there were no performance or any other type of adverse conditions found with the generator.Analysis was completed for the returned lead portion on 04/28/2015.The electrodes were not returned for analysis and therefore, a complete evaluation could not be performed on the entire lead product.Abraded openings were found on the outer and inner silicone tubes.The dried remnants of what appeared to have once been body fluids were found inside the outer and inner silicone tubes.With the exception of the observed abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies, beyond the outer and inner tubing openings, were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.
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