IntroductionThe InSite trial is a prospective, multicenter study of sacral neuromodulation (SNM) therapy with the InterStim (R) System in subjects with overactive bladder (OAB). One of the primary aims of the study is to report on long-term safety of the tined lead. This analysis provides detailed descriptions of device-related adverse events (AEs) and surgical interventions to 12 months. MethodsAnalysis included those subjects who completed test stimulation with a tined lead, received a full implant, and reported device-related AEs out to 12 months. A Clinical Events Committee (CEC) adjudicated AEs to 12 months. ResultsDevice-related AEs occurred in 30% (82/272) of subjects, with only one considered serious. Fifty-six percent of the device-related AEs occurred between implant and 3 months. The most frequent device-related AEs were undesirable change in stimulation (12%, 32/272); implant site pain (7%, 20/272); and implant site infection (3%, 9/272). Of the 26 events of implant site pain, 13 required surgical intervention, with only two resulting in explant. Ten subjects experienced 13 events of a surgical site infection (including an additional cellulitis), five of which resolved with antibiotics and eight required explantation. The overall surgical intervention rate was 13% with the most common reasons being pain at the surgical site (4%), lack/loss of efficacy (4%), and infection (3%). ConclusionsAlthough a 30% AE rate was reported, most AEs were minor and were resolved without surgical intervention. Surgical intervention was required in 13% of subjects, with the majority being revision or replacement. Neurourol. Urodynam. 36:1136-1139, 2017. (c) 2016 Wiley Periodicals, Inc.