InjuryOBP
NEUROSTAR
Received Apr 22, 2025 · Event occurred Mar 27, 2025
Report 3004824012-2025-00008 · MDR key 21886270
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 2.X (JAPAN EXPORT ONLY)Catalog number
81-01315-101
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
35 YR · Female
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
THE SEIZURE LASTED APPROXIMATELY 30 SECONDS AND SELF-RESOLVED. THE PATIENT DID NOT SUFFER ANY LASTING EFFECTS. THE PATIENT'S PHYSICIAN STATED THAT THE CAUSE IS UNKNOWN BUT MAY HAVE BEEN DUE IN PART TO A REDUCTION IN DOSAGE OF LORAZOLAM FROM 1.5 MG/DAY TO 1.0 MG/DAY DURING THE COURSE OF TMS TREATMENT.
Description of Event or Problem
NEURONETICS' JAPANESE DISTRIBUTOR REPORTED THAT A PATIENT HAD A SEIZURE APPROXIMATELY 6 HOURS AFTER HER 15TH NEUROSTAR TMS TREATMENT. THE SEIZURE LASTED APPROXIMATELY 30 SECONDS.