FDA Adverse Event Injury Summary report: N

RTMS FOR OCD

MDR report key: 18687581 · Received February 12, 2024

Report

Report Number
MW5151360
Event Type
Injury
Date Received
February 12, 2024
Date of Event
February 1, 2024
Report Date
February 7, 2024
Manufacturer
UNK
Product Code
QCI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

HAD MY FIRST RTMS FOR OCD APPOINTMENT AND WITHIN AN HOUR HAD SUCH EXTREME ANXIETY, MY HANDS WERE SHAKING, I WAS SWEATING PROFUSELY, ELEVATED HEART RATE YET NO MENTAL ANXIETY. IT WAS CRIPPLING. WAS CONVINCED BY THE CLINIC TO TRY AGAIN AND THIS CRIPPLING ANXIETY HASN'T STOPPED SINCE. I CANNOT LIVE LIKE THIS! I HAD ZERO ISSUES WITH ANXIETY PRIOR TO RTMS. I'M LIVID! I WORKED EXTRAORDINARILY HARD TO GET RID OF MY ANXIETY OVER A YEAR AGO AND HAD COMPLETE CONTROL. I TRIED TRMS AND IT MADE IT COME BACK AS IF I HAVEN'T DONE ANY WORK AND AS IF I'M NOT ON ANY MEDS. THE ONE MEDICATION THAT HAS WORKED FOR ME, BUSPIRONE, NOW NO LONGER WORKS. I WANT TO DIE. I CAN'T GO BACK TO LIFE LIKE A HERMIT/LIVING CORPSE! THEY REALLY NEED TO TELL PEOPLE TO AVOID THIS IF THEY HAVE PRIOR HISTORY WITH EXTREME ANXIETY NO MATTER HOW WELL CONTROLLED IT IS. IT SEEMS TO ANNIHILATE ANY PROGRESS AND MAKE MEDICATIONS THAT ONCE WORKED COMPLETELY USELESS. I HAVE NO OTHER MEDICATIONS THAT WORK NOW. BUSPIRONE WAS MY LAST ONE! AND I'M ACTIVELY TAKING SPRAVATO AND IT DOESN'T TOUCH IT AT ALL. THIS IS MAKING MY DEPRESSION SO MUCH WORSE I'M BACK TO SUICIDAL IDEATION. THE VERY SUICIDAL IDEATION THAT SPRAVATO WAS STARTING TO LIFT A LITTLE. I'M BACK AT SQUARE ONE BUT NOW WITH 2 REASONS TO DISCONTINUE LIVING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
397643 RTMS FOR OCD TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER QCI UNK

Patients

Seq Age Sex Outcome Treatment
1 40 YR Female Disability B12| BUSPIRONE| GABAPENTIN| IRON | NUVARING