MAUDE Adverse Event Report: BRAINSWAY LTD. TRANSCRANIAL MAGNETIC STIMULATION OCD HELMET; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); No Code Available (3191)

Event Date 01/14/2019

Event Type  Injury  

Event Description

Brainsway tms helmet, i have major depression from cpstd and i also have ocd among other things.The depression helmet was helping immensely, then after the ocd helmet came out, i was made aware that it is supposed to be helpful for ptsd.This was not the case for me, while i had started to get better - i ended up within one to two treatments drastically and very suddenly experiencing a horrid worsening of symptoms including extremely severe anxiety and intense suicidality requiring hospitalization and other add'l treatments including ketamine to finally help rid the suicidal thoughts.It was excruciating right after i had the ocd helmet for me, personally.I had also understood it was potentially helpful for addiction, which i did not notice a difference in my thought patterns (i was and remain indeed alcohol and drug free then and now).Brainsway h1 was / is a life saver and helped my insomnia, depression, ptsd greatly though the ocd helmet just did not suit well with my brain in any way.I want others to know so they may avoid this horrid situation.I was not aware it could have that effect at all.Neurostar did not work for me.Severe worsening in health.Now i am on ritalin, gabapentin prn, zofran, and naltrexone.I have just started trileptal and restarted ritalin after a few months.I cannot take traditional antidepressants.The ritalin has gotten rid of my cravings again and is helping a lot with my sleep.Fda safety report id# (b)(4).

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATION OCD HELMET
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 9167072
• MDR Text Key: 161568706
• Report Number: MW5090272
• Device Sequence Number: 1
• Product Code: QCI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACTIVE MAGNESIUM ; GABAPENTIN PRN ; MELATONIN ; METHYLFOLATE; MULTIVITAMIN; NAC ; NALTREXONE ; OMEGA 3 ; PHOSPHATIDYLSERINE ; RITALIN ; SUBLINGUAL ; ZOFRAN
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 23 YR