Characterizing Complications of Intracranial Responsive Neurostimulation Devices for Epilepsy Through a Retrospective Analysis of the Federal MAUDE Database.

Objectives: Responsive neurostimulation is an innovative modality in the treatment of medication-refractory epilepsy for patients who are not suitable candidates for surgical intervention. While being a potentially life-changing treatment option for many individuals with epilepsy, little is known about the system's complications aside from its performance in initial clinical trials. Therefore, the goal of this study was to characterize all reported complications of the RNS system made to the Food & Drug Administration since its approval.