{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T06:09:04Z","timestamp":1793081344256,"version":"4.5.0"},"reference-count":32,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":[],"accepted":{"date-parts":[[2018,5,9]]},"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:sec>\n                  <jats:title>Background and objectives<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named \u2018Dorsal root ganglion stimulator for pain relief\u2019 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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 \u2018other\u2019 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The \u2018Dorsal root ganglion stimulator for pain relief\u2019 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rapm-2018-000007","type":"journal-article","created":{"date-parts":[[2019,1,14]],"date-time":"2019-01-14T14:04:06Z","timestamp":1547474646000},"page":"100-106","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":72,"title":["Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database"],"prefix":"10.1136","volume":"44","author":[{"given":"Eellan","family":"Sivanesan","sequence":"first","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark C","family":"Bicket","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA"},{"name":"Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven P","family":"Cohen","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA"},{"name":"Departments of Neurology and Physical Medicine & Rehabilitation, Johns Hopkins School of Medicine, Bethesda, Maryland, USA"},{"name":"Departments of Anesthesiology and Physical Medicine & Rehabilitation, Walter Reed National Military Medical Center, Bethesda, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,1,3]]},"reference":[{"key":"2025101111242234000_44.1.100.1","doi-asserted-by":"publisher","DOI":"10.1227\/00006123-199506000-00006"},{"key":"2025101111242234000_44.1.100.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1403.2010.00307.x"},{"key":"2025101111242234000_44.1.100.3","doi-asserted-by":"crossref","first-page":"690","DOI":"10.1111\/ner.12651","article-title":"Relevant anatomy, morphology, and implantation techniques of the dorsal root ganglia at the lumbar levels","volume":"20","author":"Vancamp","year":"2017","journal-title":"Neuromodulation"},{"key":"2025101111242234000_44.1.100.4","doi-asserted-by":"crossref","first-page":"1123","DOI":"10.1080\/14737175.2016.1206817","article-title":"Dorsal root ganglion stimulation approval by Administration: advice on evolving the process","volume":"16","author":"Deer","year":"2016","journal-title":"Expert Rev Neurother"},{"key":"2025101111242234000_44.1.100.5","unstructured":"Dorsal root ganglion stimulator for pain relief PMA P150004 approval letter. 2016. 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