It was reported the patient underwent a trial procedure on (b)(6) 2017 and the physician experienced difficulty in implanting the first lead and had to make multiple attempts in order to implant the lead.The following day((b)(6) 2017) the patient was not receiving effective stimulation and the abbott representative advised the patient to adjust the settings.The next day ((b)(6) 2017) the abbott representative met with the patient for reprogramming and the patient was in severe pain and her legs were swollen.The physician removed her lead and mri and doppler studies were ordered.
|