MAUDE Adverse Event Report: BRAINSWAY LTD. BRAINSWAY DEEP TMS FOR OCD; TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Memory Loss/Impairment (1958); Nausea (1970); Anxiety (2328); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 11/05/2021

Event Type  Injury  

Event Description

So i started treatment with the deeptms for ocd, and i started noticing the issues after my second treatment.When i went into work after my second treatment i was extremely nauseous.I have been having issues with my typing and spelling, i also have had short term memory loss, i lose my train of thought, i cant form my words correctly.The short term memory loss and forgetting what i was going to do is horrible.And a friend told me i sounded more anxious then i ever have.I have reached out to brainsway twice and the same person picked up the phone both times and promised i would get a call back.No calls back.I asked the second time i called with a different issue are you really going to have someone get back to me.She said she would have the brainsway rep for my area call me back.She even said she submitted it as an emergency request.I called last friday and it is going to be a week tomorrow and i have never received a call back.I wanted to talk to them before i went for my treatment monday.And she assured me i might not get the call back but that i would hear from someone.Fda safety report id# (b)(4).

• Brand Name: BRAINSWAY DEEP TMS FOR OCD
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 12820507
• MDR Text Key: 280932970
• Report Number: MW5105345
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Female