inforMED
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.

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.