Assessing Adverse Events and Failures in Magnetic Resonance-guided Focused Ultrasound Thalamotomy: An Analytic Review of the Manufacturer and User Facility Device Experience Database

Objective: This study aims to systematically identify, categorize, and analyze the adverse events associated with the InSightec Exablate 4000 System, specifically for treating essential tremors and Parkinson’s disease, as reported in the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Utilizing the MAUDE database, this study compiled and analyzed reports related to the InSightec Exablate’s MR-guided focused ultrasound system (MRgFUS) from its first report on August 29, 2017, to August 12, 2024. The data were extracted using the device identifier code “POH,” focusing on patient-related (PR) and device-related (DR) events. The reports were categorized, and trend analyses were conducted using Microsoft Excel 2021 and Jamovi software (version 2.3). Results: A total of 170 medical device reports were analyzed. The most common PR events were sensory disturbances (25.9%), balance and gait issues (27.6%), and motor impairments (25.9%). DR events included silicone membrane failures and overheating. Four deaths were reported, but none were definitively linked to the device. Interventions were needed in three cases, primarily for cerebral edema. Conclusion: This study underscores the importance of thorough preprocedural assessments and vigilant monitoring during MRgFUS thalamotomy. The findings highlight the need for ongoing refinement of safety protocols and device design to mitigate adverse events. Enhanced data reporting and further research are essential to improve patient outcomes and advance the effectiveness of focused ultrasound treatments.