MAUDE Adverse Event Report: NEURONETICS INC. NEUROSTAR TMS MACHINE; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Visual Disturbances (2140); Dizziness (2194); Anxiety (2328); Depression (2361); Cognitive Changes (2551); Balance Problems (4401); Suicidal Ideation (4429); Unspecified Heart Problem (4454)

Event Date 08/22/2022

Event Type  Injury  

Event Description

Having severe reactions to tms treatment that were not disclosed by the provider prior to treatment.Three days ago i had a severe panic attack and went to urgent care.I have never had anxiety this severe in my entire life.Today, i felt weak and so tired i could barely walk.I felt dizzy, tired, almost drunk and had double vision.I fell into a major depressive mood where i have suicidal ideation.I have told my provider that the treatments are creating new severe mental health and physiological symptoms and he doesn't seem to care.Today i had some kind of heart trouble but i didn't go to the doctor because i was just there a few days ago.I also was having visual distortions like seeing people and thinking their heads were missing.I was having psychotic symptoms like making eye contact and thinking that by making eye contact the other person wanted to do me harm.I felt like i lost the ability to feel where my body was in space and had balance issues from that.Can't concentrate at all or take care of myself or even do basic chores.Not being treated by the doctor who is billing me but by one of his "associates " who according to their website has very little experience and no formal training in tms.Take this product off the market or strictly regulate its use.I have never been in this terrible of a state physically or mentally in my entire life and i've only been doing this treatment for a week.The fda should require brain imaging prior to, before and during tms treatment.The treatment should be given by a doctor not a nurse.And the fda should require the patient to be medically tested not just answer basic questions about past medications in a speedy interview designed just to rush the insurance qualification through the system.The physician performing this medical procedure should be trained on how to do it.Tms is like brain surgery.It is not a massage.It is not a toy.The fdas failure to regulate this medical procedure has caused me harm.Fda safety report id# (b)(4).

• Brand Name: NEUROSTAR TMS MACHINE
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15283718
• MDR Text Key: 298493865
• Report Number: MW5111691
• Device Sequence Number: 1
• Product Code: OBP
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LABETOLOL; PRENATAL VITAMINS; VALIUM
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White