FDA Adverse Event Injury Summary report: N

NEUROSTAR

MDR report key: 22439054 · Received July 8, 2025

Report

Report Number
MW5172397
Event Type
Injury
Date Received
July 8, 2025
Report Date
July 2, 2025
Manufacturer
NEURONETICS INC.
Product Code
OBP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NV, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

AFTER CONCLUDING TMS (NEUROSTAR) TREATMENT IN (B)(6) 2023, I STARTED GETTING RECURRING MIGRAINES. THIS STARTED IN LATE SUMMER/EARLY FALL OF 2023 AND RAMPED UP TO BECOME A SERIOUS PROBLEM AFFECTING MY EMPLOYMENT BY (B)(6) 2024 (>10 MIGRAINES/MONTH; MY RECORDS ARE SPOTTY DUE TO THE COGNITIVE BURDENS OF THE MIGRAINES). AFTER COORDINATING WITH MY PCP AND IMPLEMENTING SOME OTHER LIFESTYLE CHANGES, THE FREQUENCY OF MIGRAINES DECREASED. MIGRAINES STILL AFFECT ME, BUT THE FREQUENCY IS NOW 3/MONTH OR LOWER. THE TMS DEVICE TARGETED MY LEFT SIDE, AND MY MIGRAINES ARE EXCLUSIVELY UNILATERAL ON THE LEFT SIDE OF MY BODY, SPECIFICALLY RIGHT BEHIND/ABOVE MY LEFT BROW/EYE. THESE MIGRAINES DO NOT RESPOND WELL TO TRIPTANS, A FIRST-LINE MIGRAINE TREATMENT. I ALSO HAVE A TIC NOW ON THE LEFT SIDE OF MY FACE, BUT THAT IS A COMMON SIDE EFFECT OF A MEDICATION I WAS TAKING CONCURRENTLY WITH TMS. I STOPPED TAKING THAT MEDICATION, BUT THE TIC REMAINS. OBVIOUSLY, I CAN'T CONFIDENTLY ATTRIBUTE ALL OF THE MIGRAINES TO THE TMS, BUT I JUST FINISHED MY EPIDEMIOLOGY DEGREE AND WANTED TO SUBMIT AN ACTUAL REPORT LINKING MIGRAINES AND TMS. HOPE THIS INFORMATION HELPS YOU ANALYZE THE SAFETY OF THIS DEVICE SOONER OR LATER. BEST WISHES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
147689 NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION OBP NEURONETICS INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Female Disability ABILIFY (15MG)| APLENZIN (522MG)| VYVANSE (30MG)