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.
Materials and methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for entries reported under "implanted brain stimulator for epilepsy" through the dates of November 1, 2013, to March 1, 2020. After correction of duplicate entries, each was sorted into complication types based on the entries' narrative descriptions.
Results: The searched yielded 241 unique complication events. The most common complications were attributed to infections (40%) and lead breaks (12%). Other reported complications included poor wound healing (10%) and intrinsic device failure (7%). Focal neurological deficits were found in 2%. Over half (67%) of the reported complications required return to the operating room for revision or explant. The remainder of the adverse events were self-resolved or treated with either medication or software adjustment.
Conclusions: Future research endeavors should attempt to optimize the implantable device for preventing infections. The data of complications provided by this review will also aid physicians in providing the most accurate informed consent for patients when deciding to undergo implantation with the responsive neurostimulation system.
Keywords: Complications; MAUDE; epilepsy; responsive neurostimulation; seizure.
Copyright © 2021. Published by Elsevier Inc.