Clinical Summary
Clinical Summary: Postmarketing Safety of Transcranial Magnetic Stimulation: A 10-Year MAUDE Database Analysis of Adverse Events and Technological Advancements
TMS is now used far beyond tightly controlled trials, including in patients with complex psychiatric comorbidity and expanding off-label indications. As clinical exposure grows, psychiatrists need real-world safety data on what gets reported after treatment, not just what appears in efficacy studies.
Design
the first comprehensive analysis of adverse event reports related to TMS submitted to the FDA’s MAUDE database
N
200 unique TMS-related reports
Population
All publicly available reports from the inception of the MAUDE database through April 2025
Duration
from the inception of the MAUDE database through April 2025
Key Findings
- Among the 200 reports, injury was the most common classification (n=191, 94.7%), followed by malfunction (n =7, 4.1%) and death (n =2, 1.2%); narrative review of both death cases revealed complex clinical contexts with no direct causality attributed to TMS.
- Across the 200 reports, 645 symptom mentions were identified; the most frequently reported symptoms were anxiety (n=53, 8.2%), neurocognitive changes (n=52, 8.0%), convulsions/seizures (n=45, 6.9%), headache (n=45, 6.9%), and depression (n =39, 6.0%).
- Report volume increased sharply after 2021, with 45 reports in 2022, 41 in 2023, 45 in 2024, and 9 reports in the first quarter of 2025; there were fewer than 15 submissions annually prior to 2021.
- The most common device problem was “Adverse event without identified device or use problem” (n=82, 41%), followed by “Insufficient information or unspecified problem code” (n=58, 29%) and “Output problem” (n=11, 5.5%).
- Temporal data were available for 181 of the 200 TMS-related reports (90.5%); the median delay between event occurrence and FDA receipt was 1.4 months (IQR: 6.85 months), with a mean delay of 6.04 months (SD: 10.13) and a maximum of 77.1 months.
Clinical Bottom Line
Postmarketing TMS safety reports were predominantly nonfatal but were rich in clinically relevant symptoms, especially anxiety, neurocognitive complaints, seizures, headache, and auditory symptoms. In practice, TMS should be paired with structured adverse-event monitoring, patient counseling, and careful protocol adherence rather than assuming trial-based tolerability fully captures real-world risk.
Practice Implications
- Monitor beyond expected scalp discomfort and headache: anxiety (n=53, 8.2%), neurocognitive changes (n=52, 8.0%), convulsions/seizures (n=45, 6.9%), tinnitus (n=36, 5.6%), and visual disturbances (n=13, 2.0%) were all reported in MAUDE.
- Screen and counsel for seizure risk before treatment, especially around protocol deviations, proconvulsant medications, and neurologic comorbidities, because convulsions/seizures appeared in 45 reports (6.9%).
- Use well-fitted hearing protection during TMS sessions and consider devices with acoustic safety features, since tinnitus (n=36, 5.6%) and hearing-related complaints (n=11, 1.7%) were reported and the article notes coil output can reach up to 120 decibels.
- Document adverse events with specific device and use details when they occur, because 82 reports (41%) were coded as “Adverse event without identified device or use problem” and 58 reports (29%) as “Insufficient information or unspecified problem code,” limiting signal detection.
