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Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database
  1. Eellan Sivanesan1,
  2. Mark C Bicket1,2 and
  3. Steven P Cohen1,3,4
  1. 1 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA
  2. 2 Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
  3. 3 Departments of Neurology and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, Bethesda, Maryland, USA
  4. 4 Departments of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Bethesda, Maryland, USA
  1. Correspondence to Eellan Sivanesan, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD 21287, USA; esivane1{at}jhmi.edu

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.

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Footnotes

  • Funding ES received support from a Stimulating and Advancing ACCM Research (StAAR) seed grant (E.S.) from the Department of Anesthesiology and Critical Care Medicine at Johns Hopkins University and the National Institute of General Medical Sciences (T32GM075774). MCB received support from the Foundation for Anesthesia Education and Research (FAER). SPC received support from the Centers for Rehabilitation Sciences Research, U.S. Dept. of Defense.

  • Competing interests SPC has served as a consultant to Abbott in the past 3 years on the topic of radiofrequency ablation. All other authors declare no conflicts of interest.

  • Patient consent Not required

  • Provenance and peer review Not commissioned; externally peer reviewed

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