Frequently Asked Questions

Most TMS adverse event reports were classified as injuries, and the reported events were predominantly nonfatal. After deduplication, the study analyzed 200 unique MAUDE reports, of which 191 (94.7%) were classified as injury, 7 (4.1%) as malfunction, and 2 (1.2%) as death. The authors noted that narrative review of both death reports found complex clinical contexts and no direct causality attributed to TMS.

The most frequently reported symptoms were anxiety (n=53, 8.2%), neurocognitive changes (n=52, 8.0%), convulsions or seizures (n=45, 6.9%), headache (n=45, 6.9%), and depression (n=39, 6.0%). Across the 200 reports, there were 645 symptom mentions because many reports included more than 1 symptom. Other commonly reported symptoms included pain (n=36, 5.6%), tinnitus (n=36, 5.6%), emotional dysregulation (n=35, 5.4%), sleep dysfunction (n=28, 4.3%), and dizziness or vertigo (n=26, 4.0%).

Convulsions or seizures appeared in 45 of 645 symptom mentions (6.9%) in the MAUDE dataset, making them one of the more frequently reported symptoms. The authors caution that MAUDE is a passive surveillance system and should be interpreted as a source of qualitative safety signals rather than incidence estimates. To contextualize this, they cite a separate 2021 analysis reporting a seizure rate of 0.31 per 10,000 sessions and 0.71 per 1,000 patients, supporting the view that seizures remain rare but serious adverse events.

No causal conclusion can be drawn from this study. Neurocognitive changes were reported in 52 symptom mentions (8.0%) in MAUDE entries, but the authors emphasize that MAUDE data are descriptive and do not establish causality. They also note that prior evidence cited in the paper, including a meta-analysis of 30 randomized trials and a later review of 31 trials, did not find consistent cognitive impairment with rTMS.

Yes. Tinnitus was reported in 36 symptom mentions (5.6%), and hearing-related complaints such as hearing loss or hearing impairment were reported in 11 mentions (1.7%). The article states that coil output can reach up to 120 decibels, exceeding the National Institute for Occupational Safety and Health threshold of 85 dB, and therefore says well-fitted hearing protection is essential during TMS sessions.

Report volume increased sharply after 2021. There were fewer than 15 submissions annually before 2021, followed by 45 reports in 2022, 41 in 2023, 45 in 2024, and 9 reports in the first quarter of 2025. The authors state that this rise coincided with expanded clinical use and greater awareness of regulatory reporting.

The largest share of reports was attributed to Neuronetics, Inc (n=91, 45.5%), followed by BrainsWay Ltd (n=37, 18.5%), The Magstim Company Ltd (n=28, 14.0%), and MagVenture A/S (n=25, 12.5%). Neurosoft Ltd accounted for 4 reports (2.0%), MAG & More GmbH for 1 report (0.5%), and 14 reports (7.0%) had no manufacturer identified. The authors caution that these counts could not be normalized to device usage volume, so they should not be interpreted as comparative safety rankings.

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%). The first 2 categories were reported mainly from Neuronetics and BrainsWay. The authors describe device problem coding beyond these categories as heterogeneous and often limited to isolated cases.

Among the 181 reports with usable dates, the median delay from event occurrence to FDA receipt was 1.4 months (IQR 6.85 months), and the mean delay was 6.04 months (SD 10.13). The shortest delay was 0 months and the longest was 77.1 months. Nineteen of the 200 reports (9.5%) were excluded from this analysis because of missing event dates (n=17) or implausible date sequencing (n=2).

MAUDE data can identify safety signals, but they cannot determine true incidence or causality. The authors state that MAUDE is a passive surveillance system that is subject to underreporting, variable report quality, inconsistent coding, and reporting delays, and that event classifications are assigned by reporters rather than independently verified by the FDA. They also note that device usage volume by manufacturer was unavailable, so manufacturer report counts could not be normalized.

The authors state that several device advances may improve safety and tolerability, including double-containment coils that reduce acoustic output, advanced pulse-shaping systems using IGBTs and MOSFETs, and magnetic resonance imaging-guided personalization. They also describe broader evolution from circular to figure-of-eight coils for greater focality and the use of H-coils for deeper stimulation. In the article's interpretation, these innovations may help reduce stimulation burden and improve user experience, although the MAUDE analysis itself was descriptive rather than causal.