Additional information was received that no patient manipulation or trauma was known to have occurred which may have contributed to the high impedance.The explanted generator and lead were received for analysis.Analysis of the explanted generator showed proper functionality of the pulse generator in its ability to provide appropriate programmed output currents.A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no performance or any other type of adverse conditions found with the pulse generator.Review of the generator's internal data showed that the high impedance occurred sometime on or prior to (b)(6) 2014.Analysis of the explanted lead was completed and confirmed discontinuity of both the positive and negative quadfilar coils in the body region of the returned lead portions.Abraded openings of both the outer and inner tubing were observed as well, which provided paths for the observed fluid leaks.Furthermore, pitting was observed near the break locations.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
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