Journal: Brain Stimulation (2021)
Authors: A. Tendler, T. Harmelech, R. Gersner, Y Roth
Background:
The most serious acute TMS device related adverse event is a TMS-provoked seizure. It is crucial for TMS manufacturers to report and continually update their seizure rate metrics.
Objective:
Measure the seizure rate of BrainsWay Deep TMS based on the number of total patients treated at time of publication.
Methods:
All adverse events related to Deep TMS treatment are reported to BrainsWay’s Chief Medical Officer, including a discussion with the treating provider in cases of potential harm to patient. The number of patients treated by Deep TMS is estimated from treatment cap orders – 1 cap per patient.
Results:
From 2010 to October 2020, 55 seizures were reported. 14 of those occurred when instructions for use were followed correctly (pIFU). The number of patients treated during that period was 94,857, resulting in an overall seizure frequency of 0.00058 and pIFU seizure frequency of 0.00015.
Conclusions:
This suggests an overall seizure frequency of 6:10,000 patients and 2:10,000 patients pIFU. This comprehensive listing of every seizure provoked by an H-coil reaffirms the safety of Deep TMS.