Initial report was that a patient was referred for replacement due to eos.Further information was received that the patient's generator was replaced due to high impedance.The patient's neurologist did not feel that the lead was compromised but that the high impedance was due to the upgraded tablet software and the fact that the patient had a m102 device.The neurologist stated in his notes to the surgeon that the impedance was higher than normal and that the surgeon should visually inspect and try a new generator before replacing the lead.Per the received implant card, only the patient's generator was replaced.For model 102/102r generators programmed to output currents > 1 ma , it was observed that system diagnostics using m3000 v1.0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1.5 software would display a false high impedance.This is likely what the physician was referring to when indicating that he believed the upgraded tablet software was the cause of the high impedance.The generator has not been received to date.No other relevant information has been received to date.
|