MAUDE Adverse Event Report: RTMS FOR OCD; TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER

Patient Problems Tachycardia (2095); Anxiety (2328); Shaking/Tremors (2515); Suicidal Ideation (4429); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2024

Event Type  Injury  

Event Description

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.

• Brand Name: RTMS FOR OCD
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER
• MDR Report Key: 18687581
• MDR Text Key: 335148492
• Report Number: MW5151360
• Device Sequence Number: 1
• Product Code: QCI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: B12; BUSPIRONE; GABAPENTIN; IRON ; NUVARING
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White