MAGPRO R30 TMS DEVICE
Received Jan 8, 2021 · Event occurred Jan 6, 2021
Report MW5098747 · MDR key 11147307
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Magventure A/sModel number
MAGPRO R30Catalog number
P/N 9016E0721
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
18 YR
- Convulsion, Tonic
- Loss of consciousness
- Vaso-Vagal Response
- Convulsion, Tonic
- Loss of consciousness
- Vaso-Vagal Response
Narrative
Description of Event or Problem
DURING THE MAPPING OF THE MOTOR THRESHOLD WITH THE DEVICE, THE PATIENT HAD AN ALMOST 40-SECOND EPISODE (PRESUMED A SEIZURE) WHICH STARTED WITH STIFFENING THROUGHOUT THE BODY AND THEN RHYTHMIC BILATERAL GENERALIZED TONIC-CLONIC MOVEMENTS IN LOWER AND UPPER EXTREMITIES AND IN EYES WHICH LOOKED UP AND TO THE LEFT. DURING THE LATER PART OF THE 40-SEC EPISODE, SHE GROANED. SHE WAS UNCONSCIOUS FOR ALMOST ONE MINUTE FOLLOWING THE EPISODE. WE CALLED 911 AND SENT HER TO THE ER TO HAVE A NEUROLOGIC WORKUP. IMPORTANT POINTS ARE THAT THE PATIENT HAD KNOWN VASO-VAGAL RESPONSES TO MEDICAL PROCEDURES SUCH AS BLOOD DRAWS AND HAD MEDICAL AND NEUROLOGIC WORKUP WHICH "RULED OUT SEIZURES" (MRI AND EEG IN PAST). FDA SAFETY REPORT ID # (B)(4).