Consequently, the FDA acknowledges that the incidence or prevalence of an event should not be derived from this database alone and that these data in and of itself should not be used to compare devices or determine temporal changes in event rates. As manufacturers often rely on facilities or health-care providers to inform them of adverse events, not all events are captured. Patients, family, and healthcare providers are also able to report events as voluntary reporters however, this is an uncommon occurrence. Device user facilities encompass hospitals, outpatient diagnostic or treatment facilities, nursing homes, and ambulatory surgical centers. Device manufacturers, importers and device user facilities are considered mandatory reporters by the FDA and must submit known complications. 15 This information is available to the public online or with a Freedom of Information Act (FOIA) request directed to the FDA. The FDA supports the Manufacturer and User Facility Device Experience (MAUDE) database for reporting of medical device-related adverse events. It is unknown whether these rates are comparable with DRG stimulation or if there are unique complications specific to this new modality. 10– 14 However, stark differences in design and implantation technique limit similarities and possibly generalization of this data to DRG stimulation.
The most comparable safety data comes from conventional SCS, which has a reported incidence of complications ranging from 32% to 43%. Outside of safety reporting in clinical trials, a literature review did not reveal any publications focusing specifically on complications associated with DRG stimulation. Since the device is relatively new, scant data are available regarding complications. 3, 4 Although the DRG stimulator received US Food and Drug Administration (FDA) approval only recently, the device has been available in Europe and Australia since receiving regulatory Conformité Européene (CE) Mark approval in late 2011. Compared with spinal cord stimulation (SCS) leads, these DRG specific leads contain a smaller cross sectional area, contact size, intercontact spacing, less rigidity and are implanted via a unique contralateral technique. 1, 2 Limitations of traditional systems for DRG stimulation led to the development of Abbott Laboratories, Austin, Texas, USA proprietary device designed specifically for this purpose. 1 This report and another early case used traditional dorsal column system components, modifying the procedural technique to facilitate placement overlying the DRG. The earliest report of stimulation directly targeting the DRG appears to have occurred in 1995 for the treatment of lumbar discogenic pain. Sysantos, Abbott, personal communication, December 1, 2017) performed in the USA since approval in February 2016.
Dorsal root ganglion (DRG) stimulation is rapidly emerging as a treatment for chronic pain, with an estimated 5000 trials and 3000 permanent implants (J.