Description of Event or Problem · 0
IT WAS REPORTED IN A LITERATURE ARTICLE (AMIRDELFAN, K., KAPURAL, L., YU, C., DOUST, M.W., GLINER, B.D., VALLEJO, R., SITZMAN, B.T., MORGAN, D.M., YEARWOOD, T.L., BUNDSCHU, R., YANG, T.S., BENYAMIN, R., BURGHER, A.H.. SUBJECT SATISFACTION WITH PARESTHESIA-FREE 10 KHZ AND PARESTHESIA-BASED LOW-FREQUENCY SPINAL CORD STIMULATION SYSTEMS (10542). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 112.) THAT 74.5% OF 10 KHZ SCS SUBJECTS IN THE SENZA-RCT STUDY REPORTED USING THEIR REMOTE CONTROL TO ADJUST THERAPY SETTINGS COMPARED WITH 87.5% OF LF-SCS SUBJECTS. IT WAS ALSO REPORTED THAT OF THE SUBJECTS USING THEIR REMOTE CONTROL, 0.0% OF 10 KHZ SCS REPORTED USING IT AT LEAST ONCE PER DAY COMPARED WITH 40.5% OF LF-SCS SUBJECTS. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).