inforMED
InjuryGWF

MAGVENTURE

Received Jun 21, 2023 · Event occurred Jun 16, 2023

Report MW5118710 · MDR key 17186313

Device

Generic name

Stimulator, Electrical, Evoked Response

Model number

MAGPRO R30

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

24 YR · Female

  • Fatigue
  • Tachycardia
  • Confusion/ Disorientation
  • Convulsion/Seizure
  • Fatigue
  • Tachycardia
  • Confusion/ Disorientation
  • Convulsion/Seizure

Narrative

Description of Event or Problem

TRANSCRANIAL MAGNETIC STIMULATION APPLIED TO RIGHT SIDE AT 120% MOTOR THRESHOLD CAUSED SEIZURE. SEIZURE ACTIVITY LASTED 2 MINUTES WITH POST-ICTAL CONFUSION LASTING 10 MINUTES, FULL RECOVERY WITH NORMAL MENTAL STATUS AT 15 MINUTES AFTER SEIZURE ACTIVITY ENDED. NO MEDICAL INTERVENTION REQUIRED. PATIENT WAS DISCHARGED FROM OUTPATIENT CLINIC TO HOME WITH BOYFRIEND AT 35 MINUTES AFTER EVENT. SHE REPORTED FEELING TIRED, BUT NO OTHER RESIDUAL SYMPTOMS. VITAL SIGNS MEASURED AT 15 MINUTES AFTER EVENT: HR 102, BP 116/64, RR 15. TREATMENT TO LEFT SIDE WAS CONDUCTED PRIOR TO RIGHT SIDE WITHOUT COMPLICATION. EVENT OCCURRED AT TREATMENT #22. MOTOR THRESHOLD AND MAPPING CONFIRMATION WERE CONDUCTED 1 DAY PRIOR TO EVENT, AT TREATMENT #21. MOTOR THRESHOLD MEASURED AT 56, TREATMENT INTENSITY 67.