MAUDE Adverse Event Report: TRANSCRANIAL MAGNETIC STIMULATION / MERT THERAPY FOR AUTISM; TRANSCRANIAL MAGNETIC STIMULATOR

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Sleep Dysfunction (2517); Speech Disorder (4415)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I have a 5 year old son who is autistic.My wife and i took him to the brain treatment centre in (b)(6) for trial of mert treatment, which is a form of transcranial magnetic stimulation that is proposed to improve some core symptoms of autism.This was spanned out over a period of 6 weeks from (b)(6) to (b)(6) 2022.We were well aware that this treatment is still not fda approved and is still a largely experimental form of therapy.However the treatment is said to be harmless, so we assumed that the worst that could happen would be a lack of any positive response to the treatment.We are resident in (b)(6) and had to make a long trip to the usa to get our child better.My son went through 5 weeks of this mert treatment.He seemed to take well to it for the first 3 weeks so we decided to continue the treatment.After the 3rd week there was a sudden downturn with worsening of core symptoms epitomised by a complete loss of the little speech he had.His sleep patterns worsened and he was more averse to taking food.He also began experiencing bouts of severe "pain", which were characterised by him incessantly crying and rolling on the floor.We were informed that the doses of magnetic stimulation would be adjusted and he would be better.This however did not happen so we decided to abort the treatment after 5 weeks and did not in fact complete the pre planned 6 weeks of therapy.As i have written, we were well aware that this treatment is not fda approved but we were not aware of its potential possible harm.My child has since regressed and all his objective scores e.G.Atec score for autism has worsened.Its 5 months after the therapy now and we are worse off that we were before the therapy was commenced.We have decided to report this case so that if possible the fda may assess this treatment and regulate it in such a way as not to cause harm to any more of our children.I am aware that some children may benefit from the therapy, but i feel more work still needs to be done to rather prevent more harm to some children like my son.I am not sure if this is the right platform to report this issue, i would appreciate further guidance on where to report it if this is not the right place.Fda safety report id# (b)(4).

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATION / MERT THERAPY FOR AUTISM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• MDR Report Key: 15589183
• Report Number: MW5112560
• Device Sequence Number: 13008447
• Product Code: OBP
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTIVITAMIN SUPPLEMENTS
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 19 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American