How to Document and Report TMS Adverse Events
How should clinicians document and report adverse events during transcranial magnetic stimulation to improve safety surveillance?
When adverse events occur during TMS, incomplete or nonspecific documentation weakens postmarket signal detection and delays safety learning. This guide applies to clinicians and treatment programs that want to record TMS adverse events in a way that is more useful for regulatory and quality-improvement purposes.
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Record the clinical event as soon as it occurs
Document the adverse event promptly rather than waiting for delayed retrospective reconstruction. The article found a median delay of 1.4 months from event occurrence to FDA receipt among 181 evaluable reports, with a mean delay of 6.04 months and a maximum of 77.1 months. Faster documentation supports more timely safety signal detection.
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Capture the full symptom profile
Record all symptoms present, not just the most prominent complaint, because many reports contained multiple symptom mentions. Include clinically relevant neuropsychiatric, sensory, and neurologic symptoms such as anxiety, neurocognitive changes, convulsions or seizures, headache, depression, pain, tinnitus, emotional dysregulation, sleep dysfunction, dizziness or vertigo, suicidal ideation, visual disturbances, and hearing-related complaints.
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Document device and use details specifically
Avoid nonspecific descriptions when an adverse event occurs. The article showed that 41% of reports were coded as adverse event without identified device or use problem and 29% as insufficient information or unspecified problem code, limiting interpretability. Include the device and operational details available in the clinical record so the event is less likely to be classified as unspecified.
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Note possible protocol and patient risk contributors
When relevant, document factors that may have contributed to the event, especially for seizures. The article identifies protocol deviations, proconvulsant medications, and neurologic comorbidities as key seizure risk factors. Recording these factors can help distinguish device issues from treatment-process or patient-level contributors.
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Include manufacturer identification when known
Specify the manufacturer when it is available in the treatment record. In the study, 14 reports lacked manufacturer identification and were excluded from stratified comparisons. Complete manufacturer information improves the usefulness of postmarket analyses.
Clinical Considerations
- The article did not test a specific reporting form or clinic workflow, so this guide is limited to documentation elements and timing concerns directly discussed in the paper.
- MAUDE reports vary in quality and completeness, and the database is subject to underreporting.
- Reporter-assigned classifications in MAUDE do not establish causality.
- Reporting delays can materially limit the timeliness of public health response.
Bottom Line
The most useful TMS adverse-event reports are prompt, symptom-complete, and specific about device, manufacturer, and possible protocol or patient risk factors.
