Post-market device experience reports of dorsal root ganglion stimulation: a 10-year retrospective analysis of the FDA MAUDE database

Background Dorsal root ganglion stimulation is an established therapy for focal neuropathic pain, including complex regional pain syndrome. Post-market adverse event data spanning the full post-approval decade are lacking. Methods We retrospectively analyzed dorsal root ganglion stimulation-related U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) reports (January 2016–May 2026). Records underwent multi-stage deduplication, combining a blinded manual review by four independent investigators with a custom two-stage algorithmic protocol to merge complex residual duplicates. Thematic analysis was performed using NVivo V.15. Results Following deduplication, 10 532 reports were included. 10 334 were reported as serious injuries. Among reports with documented sex (n = 4796), 60.2% were female. Age was reported in 4329 records, and the median was 44 years (IQR: 36–50). The USA contributed 88.4% of geographically identified reports. Most reported patient-related issues were “inadequate pain relief” (n=7135), followed by “failure of implant” (n=781), “implant pain” (n=548), and “cerebrospinal fluid leakage” (n=274). “Migration” was the most prevalent device problem code (n=2426), followed by “high impedance” (n=1560), “therapeutic or diagnostic output failure” (n=1167), and “fracture” (n=1160). Implant-year data were right-truncated. Conclusion Reported dorsal root ganglion stimulation events are dominated by lead migration, impedance abnormality, and fracture frequently co-presenting with persistence of symptoms. These patterns support engineering attention to lead fixation and structured hardware surveillance within routine follow-up. Because MAUDE lacks denominator data, results are signal generating. Prospective registries with implant-level denominators are needed to define true complication rates and distinguish hardware failure from programming-related efficacy loss.