User Guide

Safety Information
37
Clinical Experience-Safety Clinical data has been collected during a clinical study of the PRECISION™ System. As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had
CSF Leak 5 0.5% 0.6% Over/Under Stimula- tion, Ineffective Pain Control
46 4.4% 5.2%
Intermittent Stimula- tion
00%0%
Pain Over Implant 16 1.5% 1.8% Allergic Reaction 6 0.6% 0.7% Skin Erosion 0 0% 0% Lead Breakage 35 3.3% 4.0% Hardware Malfunction 22 2.1% 2.5% Loose Connection 0 0% 0% Battery Failure 2 0.2% 0.2% Other 45 4.3% 5.1%