Product analysis of the returned generator was completed on (b)(4) 2015.The generator performed according to functional specifications.Analysis in the product analysis lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.Analysis of the lead was completed on (b)(4) 2015.Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 306mm from the end of the connector boot.Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material.Pitting was observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.During the visual analysis the (+) connector ring quadfilar coil appeared to be stretched and kinked approximately 273mm past the end of the cut / torn inner silicone tubes with a spot-weld / slug attached to the end.Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon.The abraded openings and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.The abraded openings found on the (-) connector pin inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing.For the observed dried remnants of what appeared to have once been body fluids found inside the (+) connector ring inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process.What appeared to be white deposits were observed on the outer silicone tubing.Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies 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, and no other discontinuities were identified.
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