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

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Speech Disorder (4415); Dysgeusia (4424); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 11/01/2021

Event Type  Injury  

Event Description

I had tms treatment for my severe, uncontrollable anxiety.My first treatment was with brainsway for anxiety.Although brainsway promoted his product for ocd which i actually needed, but they didn't provide treatment in (b)(6) for ocd and i had to go ahead with the treatment for anxiety.It wasn't bad, no major side effects, but didn't help either.My therapist suggested that i definitely should try treatment for ocd.I finally found neurostim in (b)(6).The nurse practitioner evaluated me and also advised tms for ocd.Soon after staring with the treatment i suffered some sort of memory loss which freaked me out and i was forced to take lorazepam again to calm me down.I also noticed some speech problems, like my tongue and brain didn't cooperate.Some words came out either weird or with missing letters.Constant headaches, eye and scalp pain etc.The treatment with the coils were very painful, especially when raising the stimulation level.And there was a certain level that one had to reach in order to profit from it.I was desperate, i really couldn't live with my anxiety anymore, so i said i will take the pain as long as i will get better.But i didn't, instead i'm anxious that my memory loss could happen again and that's causing me tremendous fear which brings my life completely upside down.I stopped treatment after the 14th.Visit.I told the technician was happened to me and she looked at me in disbelief.Just a few days later my eye pain (especially right eye and swollen) got worse, also right ear pain very bad, also partially lost my sense of taste out of the blue.I had two covid tests done, both negative.First they thought it's allergies, then some sort of virus, but after 10 days i haven't shown any improvement.I believe that these symptoms happened due to the tms treatment.There are dozens of other ppl who also suffered similar and even worse side effects.This cannot be right, tms treatment clearly has sometimes irreversible side effects.I would appreciate if some could contact me to discuss further details.Fda safety report id # (b)(4).

• Brand Name: NEUROSTIM TMS TREATMENT
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 12934636
• MDR Text Key: 281879366
• Report Number: MW5105814
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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: METOPROLOL; PAXIL
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White