Adverse Event Reporting

The mandatory, structured capture and reporting of harms during a trial — from surgical complications, infection, and device malfunction to unexpected physiological or psychological effects — categorized by seriousness and by whether they are device- or procedure-related. Serious adverse events and unanticipated adverse device effects must be reported to the ethics board and the regulator within defined timelines, and can trigger protocol changes, enrollment holds, or termination of the study.

For implanted BCIs the safety database is small and events are hard to attribute — is a mood change the disease, the surgery, the device, or coincidence? — so both over- and under-reporting distort the picture. Systematic, prospective adverse-event tracking that continues into long-term follow-up and post-market surveillance is the backbone of the benefit–risk assessment on which regulators and ethics boards rely.