Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database. Issue 1 (January 2019)

• Record Type: Journal Article
• Authors: Sivanesan, Eellan; Bicket, Mark C; Cohen, Steven P
• Is Part Of: Regional anesthesia and pain medicine. Volume 44:Issue 1(2019)
• Publication Date: 2019-01
• Subjects: Conduction anesthesia -- Periodicals; Pain medicine -- Periodicals; 617.964
• DOI: 10.1136/rapm-2018-000007
• Languages: English
• ISSNs: 1098-7339

Abstract

Abstract : Background and objectives: Dorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality. Methods: We queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named 'Dorsal root ganglion stimulator for pain relief' reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections. Results: We identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and 'other' complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively. Conclusions: The 'Dorsal root ganglion stimulator for pain relief' device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.