FDA Adverse Event Injury Summary report: N

MAGSTIM TMS

MDR report key: 24453951 · Received February 26, 2026

Report

Report Number
MW5184417
Event Type
Injury
Date Received
February 26, 2026
Date of Event
August 1, 2025
Report Date
February 22, 2026
Manufacturer
MAGSTIM COMPANY, LTD.
Product Code
OBP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I RECEIVED TMS BY A MAGSTIM DEVICE IN (B)(6) AT (B)(6) BEGINNING ON (B)(6) 2025 TO (B)(6) 2025. ADVERSE EFFECTS STARTED ON DAY 4, WHERE I TOLD THE TECHNICIAN ABOUT THE NEGATIVE THOUGHTS FLOODING IN AND EMOTIONS. THEY ENSURED ME IT WAS A PART OF THE PROCESS AND TO "THINK POSITIVE." BY DAY 18 I WAS STARTING TO REALLY SPIRAL AND HAVE OVERWHELMING ANXIETY, THE TECHNICIAN EVEN LOOKED CONCERNED. THAT'S WHEN THEY HAD ME SWITCH OFFICES TO THE (B)(6) LOCATION WHERE ONE OF THE TECHNICIANS THERE TOLD ME THE MACHINE WAS BROKEN AT THE (B)(6) LOCATION AND THAT WAS THE REASON FOR THE CHANGE. I REMEMBER ALMOST EVERY SESSION AT THE (B)(6) LOCATION FEELING THE PULSE BEHIND MY LEFT EYE, WHEN I SWITCHED TO THE (B)(6) LOCATION, I NEVER EXPERIENCED THAT SENSATION. BUT BY THEN THE ANXIETY WAS OVERWHELMING AND I STARTED HAVING FLASHBACKS AND DAY 20 IS WHEN THE DISSOCIATION STARTED. AFTER COMPLETION, I STARTED HAVING PANIC ATTACKS AND HAD TO QUIT MY JOB. I HAVEN'T WORKED SINCE (B)(6) AND CAN BARELY KEEP MY THOUGHTS IN ORDER. I¿VE EXPERIENCED SUICIDAL IDEATION WHICH I¿VE NEVER EXPERIENCED AND ENDED UP HAVING TO GO INPATIENT TWICE. FOUND OUT THROUGH THE INPATIENT PSYCHIATRIST I AM BIPOLAR. THE MEDICATION THEY GAVE ME (WELLBUTRIN) PRIOR TO STARING TMS STARTED A MANIC EPISODE WHICH I WAS UNAWARE OF WHAT WAS HAPPENING, AND TMS EXACERBATED IT CAUSING WHAT I BELIEVE IT A TRAUMATIC BRAIN INJURY (TBI). THE EXPERIENCE IN ITSELF HAS LEFT ME DEBILITATED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
515316 MAGSTIM TMS TRANSCRANIAL MAGNETIC STIMULATOR OBP MAGSTIM COMPANY, LTD.

Patients

Seq Age Sex Outcome Treatment
1 35 YR Male Hospitalization 5MTHF.| LAMICTAL 100MG.| LDN 6MG.| LITHIUM OROTATE.| OMEGA 3.| TYLENOL.| VITAMIN D.