InjuryOBP

NEUROSTAR

Received Jun 30, 2025 · Event occurred Mar 1, 2025

Report 3004824012-2025-00038 · MDR key 22366455

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

NEUROSTAR 2.0

Catalog number

81-01315-000

Product problems

Patient-Device Incompatibility
Patient-Device Incompatibility

Patient

38 YR · Female

Convulsion/Seizure
Convulsion/Seizure

Narrative

Additional Manufacturer Narrative

THE PATIENT WAS TAKING THREE MEDICATIONS THAT CAN LOWER SEIZURE THRESHOLD. BASED ON THE INFORMATION AVAILABLE, IT CAN NOT BE RULED OUT THAT TMS COMBINED WITH THE MEDICATIONS MAY HAVE CONTRIBUTED TO SEIZURES.

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A FORMER TMS PATIENT THAT ALLEGES SHE STARTED HAVING SEIZURES ABOUT 5 MONTHS (MARCH 2025) AFTER HER TREATMENT ENDED IN OCTOBER OF 2024. SHE STATED HER FIRST EPISODES REQUIRED HOSPITALIZATION FOR 3 DAYS.

Additional Manufacturer Narrative

SUPPLEMENT 01 WITH CORRECTED DEVICE MODEL NUMBER, SERIAL NUMBER, UDI NUMBER AND PREMARKET SUBMISSION NUMBER.