The Product Surveillance Registry (PSR) is a prospective, long-term, multi-center global registry to monitor the performance and safety of Medtronic SCS systems. The current analysis identified 399 patients with an initial device implant of an Intellis system from 30 centers on three continents as of the report cut-off date of 30-Apr-2019. As the registry enrolment and follow-up are ongoing, baseline and 6-month follow-up paired data were available for 111 subjects (EQ-5D UK Index Value score).
Our analysis showed statistically significant and clinically-relevant improvements in Health-Related Quality of Life. These improvements were observed in subsets of patients with baseline general pain score ≥ 5 and those with Failed Back Pain or other primary indications.

IMPROVEMENT OF HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SPINAL CORD STIMULATION: DATA FROM THE PRODUCT SURVEILLANCE REGISTRY