Postmarketing Safety of Transcranial Magnetic Stimulation: A 10-Year MAUDE Database Analysis of Adverse Events and...

Background: Transcranial magnetic stimulation (TMS) is an FDA-cleared neuromodulation technique with expanding clinical applications beyond major depressive disorder. Despite increasing utilization, there has been no published, device-agnostic analysis of TMS-related adverse events (AEs) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

Objective: To characterize the real-world safety profile of TMS devices based on MAUDE-reported AEs, including symptom patterns, manufacturer-level variations, device issues, and reporting delays, while contextualizing findings through a review of technological advancements in TMS.

Methods: All reports under device code OBP were extracted from MAUDE through April 2025. After deduplication, 200 unique reports were analyzed descriptively. A focused literature review was also conducted to trace safety and innovation trends in TMS device development.

Results: Of 200 reports, 94.7% involved injury, 4.1% malfunction, and 1.2% death. Common symptoms included anxiety (8.2%), neurocognitive changes (8.0%), seizures (6.9%), headache (6.9%), and tinnitus (5.6%). Neuronetics accounted for 45.5% of reports, likely reflecting market share. Median reporting delay was 1.4 months, with some exceeding 6 years. The literature review identified major innovations, including figure-of-eight and H-coils, double-containment coils, seizure risk screening, and advanced circuitry (eg, insulated-gate bipolar transistors and metal-oxide-semiconductor field-effect transistors) enabling magnetic resonance imaging-guided and accelerated protocols. Exploratory developments include wearable systems, auricular stimulation, and artificial intelligence-based individualization.

Conclusion: MAUDE data provide novel insights into TMS safety in real-world settings. Although serious AEs are rare, standardized reporting and continued device innovation are essential to ensure safe and effective clinical use.