Key Takeaways
Extended Takeaways
- MAUDE reporting accelerated after 2021, with 45 reports in 2022, 41 in 2023, and 45 in 2024, suggesting that clinicians may encounter more postmarketing safety signals as TMS use expands across approved and off-label indications.
- Most reports contained more than 1 symptom, with 645 symptom mentions across 200 reports; anxiety (n=53, 8.2%) and neurocognitive changes (n=52, 8.0%) were reported more often than headache (n=45, 6.9%), so post-session assessment should not focus only on expected somatic complaints.
- Seizures appeared in 45 reports (6.9%), but the article notes that a separate session-based analysis found a seizure rate of 0.31 per 10,000 sessions (0.71 per 1,000 patients), reinforcing that MAUDE data are useful for signal detection but should not be interpreted as incidence estimates.
- Reporting lag was substantial: among 181 evaluable reports, the median delay to FDA receipt was 1.4 months (IQR: 6.85 months), the mean was 6.04 months (SD: 10.13), and the maximum was 77.1 months, which can limit the timeliness of safety surveillance.
- Manufacturer counts were dominated by Neuronetics, Inc (n =91, 45.5%), BrainsWay Ltd (n =37, 18.5%), The Magstim Company Ltd (n=28, 14.0%), and MagVenture A/S (n=25, 12.5%), but the authors caution that report volume cannot be normalized to device utilization and should not be read as a comparative safety ranking.
- Device problem coding was often nonspecific, with “Adverse event without identified device or use problem” in 82 reports (41%) and “Insufficient information or unspecified problem code” in 58 reports (29%), highlighting the value of documenting coil, protocol, and operational details when adverse events occur.
