Complications of deep brain stimulation for drug-resistant epilepsy: an analysis from the MAUDE database.

BACKGROUND

Deep brain stimulation (DBS) is an increasingly promising approach for patients with drug-resistant epilepsy (DRE). However, there are limited studies characterizing patient complications from DBS placement.

MATERIALS AND

METHODS

Using reports from the Manufacturer and User Facility Device Experience (MAUDE) database from January 2018 through March 2024, we systematically analyzed available data on patient complications/complaints, management strategies, and clinical outcomes. Only data from DBS implantations specifically to treat DRE were collected and analyzed.

RESULTS

A total of 151 reports involving DBS treatment of DRE were analyzed. The most common DBS complications were device-related problems (DRPs, 95/151 [62.9%]) and patient complaints (PCs, 66/151 [43.7%]). The percentages exceed 100% because the categories overlap; some cases may fall into both categories, indicating that items in one category can also be included in another. The most prevalent DBS device-related complications included impedance issues (34/95 DRPs, 35.8%), device failure (32/95 DRPs, 33.7%), inadequate simulation (14/95 DRPs, 14.7%), and lead breaks (13/95 DRPs, 13.7%). The most prevalent patient complaints were worsening of seizure activity (20/66 PCs, 30.3%), psychiatric changes (9/66 PCs, 13.6%), and neurocognitive behavioral changes (8/66, 12.1%). Of the 151 reports, surgical intervention occurred for 20 (13.2%) patients; device failure had a surgical intervention rate of 9/32 (28%) while impedance issues had a rate of 7/34 (21%). Infections resulted in resolved outcomes in 6/13 (46.2%) of reports, most commonly treated with device removal (9/13, 69.2%).

CONCLUSIONS

The MAUDE database helps to more clearly define the risks and complications arising from DBS implantation to treat DRE. These results will help in assessing the risks, treatment alternatives, and outcomes associated with DBS device therapy for DRE. This will facilitate enhancements in the effectiveness of the device, better management of complications, and provide more comprehensive information to ensure patients can give informed consent.