The patient's previous generator product analysis was completed.Proper functionality of the generator in its ability to provide programmed output currents was verified in the product analysis, or pa, lab.The allegation of undersensing/no r-waves detected was not duplicated in the pa lab.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No variation in the output signal was observed and the device provided the expected level of output current.Diagnostics were as expected.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.Follow up with the company representative revealed that the increase in seizures was not above the pre-vns baseline.The surgeon did not perform a pre-surgical evaluation prior to the implantation of the autostim capable generators.It was stated that at the recent surgery, they were able to match the physician's heart rate monitor exactly during heart rate verification.
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