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Published on: December 13, 2024
Complications of ReActiv8 for chronic low back pain: an analysis of the FDA MAUDE database
Rosalynn R Z Conic1, Tugba Kivanc1, Azadeh Fischer2
1Department of Pain Medicine, Mayo Clinic, Jacksonville, FL, USA.
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.
