Information was received that the patient is being referred for replacement due to battery nearing end of service.Clinic notes for the patient were also received indicating the patient had an increase in seizures and the patient's mother wanted vns turned back on as she had previously requested the output current be set to 0ma.After discussion with the mother, the device was turned back on to 1ma.During follow-up with the physician¿s office, it was indicated that the device was turned off per the mother¿s request as she did not feel the patient was benefitting from vns and device was nearing end of service.The patient then had an increase in seizures while the device was off and not delivering therapy, therefore the mother wanted the device back on as she saw the vns was helping the patient¿s seizures.The physician indicated that there was no assessment available as to whether or not the patient was benefitting from vns since the patient was first seen by him when the device was turned off and nearing end of service.He indicated that the mother did not want to proceed with a replacement at the time but will now be having a replacement due to battery nearing end of service.It was inquired about the reported low impedance and low output status by his office and indicated that was reported by mistake as there was no low impedance or known impedance issues.The physician indicated that when the device was turned back on, there were no problems with impedance either although the exact impedance value was not available.
|
Product analysis (pa) was completed on the returned generator.Although the reported allegations of ¿increased seizures¿, and ¿stimulation not perceived¿ cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified.This was successfully verified in the pa lab.In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the pulse generator), demonstrate the appropriate magnet output for the programmed settings.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.639 volts as measured during completion of the final electrical test, shows an ifi=yes condition.The data in the diagaccumconsumed memory locations revealed that 95.440% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.
|