Product analysis was completed on the generator.The generator was placed in simulated body temperature and monitored for 24 hours.The generator provided the expected current during the entirety of the monitoring period.Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances.The generator performed according to functional specifications with no anomalies found.Product analysis was completed on the suspect lead.The lead was returned in four portions.Pa verified the existence of lead discontinuities.Five fractures were identified.The majority of the coil fractures causes could not be determine due to electro etching, coil thinning, residual material or mechanical damage.One coil break was believed to be caused by stress.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.There were also inner and outer abraded openings of the tubing that provided a leakage pathway for fluids into the tubing.Setscrew marks were found on the lead connector pin which indicates that, at one point in time, a good mechanical and electrical connection was present between the generator and lead.No further anomalies were found no further relevant information has been received, to date.
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