Psychiatrist.comPostmarketing Safety of Transcranial Magnetic Stimulation: A 10-Year MAUDE Database Analysis of Adverse Events and Technological Advancements

A 10-year MAUDE database analysis of 200 TMS adverse event reports found 94.7% involved patient injury, with seizures occurring in 6.9% of cases and neurocognitive changes in 8%. As TMS expands beyond major depression into broader psychiatric applications, this is the first device-agnostic real-world safety profile published for the technology.

🧠 Clinical Considerations

• Anxiety and neurocognitive changes topped the adverse event list at 8.2% and 8.0%, symptoms psychiatrists may initially attribute to underlying psychiatric conditions rather than device effects
• Median reporting delay of 1.4 months, with some events unreported for over 6 years, suggesting real-world safety incidence is likely undercaptured in current literature
• Seizure risk at 6.9% warrants formal pre-treatment screening protocols, particularly for patients on medications that lower seizure threshold
• Serious adverse events remain rare overall, but standardized reporting gaps limit accurate risk-benefit counseling for patients

🎯 Practice Applications

• Screen all TMS candidates for seizure risk factors and concomitant seizure-threshold-lowering medications before initiating treatment
• Counsel patients that anxiety, cognitive changes, and headache are documented post-TMS adverse events, not solely symptom fluctuation
• Document any post-TMS adverse events promptly; assume underreporting is widespread across clinical settings
• Monitor neurocognitive function in patients receiving accelerated or extended TMS protocols

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