Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain

Abstract

Background Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies, including a large prospective, randomized, controlled trial. Both safety and efficacy have been demonstrated utilizing this therapeutic approach for many chronic complaints. Continued assessment of neuromodulation therapies, such as DRG stimulation, are not only an important aspect of vigilant care, but are also necessary for the evaluation for safety. Materials and Methods Safety and complaint records for DRG and spinal cord stimulation (SCS) stimulation were obtained from the manufacturer, analyzed and compiled to further assess ongoing device safety. Complaint event data were stratified according to complain type as well as overall rates. Data from similar time periods were compared between epidural neurostimulation devices by the same manufacturer as well as rates reported in the literature. Results Overall, DRG stimulation device event rates were lower or comparable to similar epidurally placed neurostimulation devices. Rates of events varied from 0 to 1.0% for DRG stimulation (n >500+ implants) which was similar to the event rate for SCS by the same manufacturer (n >2000+ implants). In comparison, complaints and adverse events ranged from 0 to 14% for SCS in the literature. Discussions The current results from a large consecutive cohort obtained from manufacturer records indicates that DRG stimulation demonstrates an excellent safety profile. Reported event rates are similar to previously reported adverse event and complaint rates in the literature for this therapy. Similarly, safety events rates were lower or similar to previously reported rates for SCS, further demonstrating the comparative safety of this neuromodulation technique for chronic pain treatment.

Effectiveness and Safety of Dorsal Root Ganglion Stimulation for the Treatment of Chronic Pain: A Pooled Analysis

“…However, it is unlikely that all possible complications have been identified in our pooled sample of 256 patients. A recent safety analysis of post‐market surveillance data collected from an internal complaint reporting and handling database showed a 3.2% event rate for DRG stimulation devices similar to that reported for SCS in the same time frame (3.1%) . The most frequently observed events in this surveillance study are also those identified by our analysis.…”

Response to “Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain”

“…We found the study by Deer et al (1) in this issue of Neuromodulation to be in contrast with the results of our recent study that also evaluated complications associated with dorsal root ganglion (DRG) stimulator implantation (2). Our study utilized the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, which is publically available (2).…”

“…In our own study, we found 87 cases of new neurologic symptoms within a smaller window: May 1, 2016, to December 31, 2017 (2). Whereas we defined this complication as "new or worsened neurologic symptoms which most commonly involve numbness, paresthesias, weakness, or pain not including musculoskeletal back pain at entry points**," we are unable to determine the definition used in the report by Deer and colleagues (1,2). Even when we scrutinized only those neurologic complications classified as severe, we still identified nine separate reports (2).…”

“…Our study utilized the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, which is publically available (2). Deer et al (1) contend that Abbott's confidential database is less prone to bias and more comprehensive without missing events, and thus overall a more accurate representation of safety reporting (2). Unlike with the MAUDE database, readers are unable to audit or confirm the company records analyzed for this report, as they are not publically available or transparent.…”

“…Unlike with the MAUDE database, readers are unable to audit or confirm the company records analyzed for this report, as they are not publically available or transparent. The authors state that although these events are from multiple sources, the primary source for this confidential database is voluntary reporting from customer complaints (1). In contrast, the FDA collects MAUDE data from both mandatory (manufacturers, importers, and device user facilities) and voluntary reporters (3).…”