Abstract
Purpose
Chronic low back pain (CLBP) is a common multifactorial condition associated with- lumbar multifidus dysfunction and impaired neuromuscular control, which ReActiv8 addresses. As its use increases, real-world post-market adverse event data are needed.Patients and methods
In this retrospective observational analysis, medical device reports (MDRs) related to ReActiv8 were extracted from the FDA Manufacturer and User Facility Device Experience (MAUDE) database 6/17/2021-12/31/2025 (n = 341). Narrative reports were categorized into procedure-related (e.g. infection, hematoma/seroma, etc.), device-related (e.g. migration, lead damage, hardware malfunction, etc.), or patient-related (e.g. pocket pain, unwanted stimulation) complications after exclusion of duplicate or miscoded events.Results
There were 331 unique MDRs describing 344 reported events. Device-related events represented the largest proportion (n = 174, 50.6%), followed by patient-related (n = 109, 31.7%) and procedure-related events (n = 61, 17.7%). Surgical technique-related factors were reported as a possible contributing factor in 12.69% (n = 42) MDRs. Reported management included revision in 195 (58.91%) and explantation in 129 (38.97%).Conclusions
This characterization of ReActiv8-associated adverse events may help identify areas relevant to patient counseling, surgical technique, and future device optimization; however, these data cannot be used to estimate complication incidence or overall device safety.