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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Headache (1880); Twitching (2172); Anxiety (2328); Depression (2361); Cognitive Changes (2551); Weight Changes (2607); Suicidal Ideation (4429); Decreased Appetite (4569)

Event Date 07/14/2021

Event Type  Injury  

Event Description

I underwent 10 treatment sessions of tms (transcranial magnetic stimulation) at (b)(6) center in (b)(6) in (b)(6) 2021.Prior to the treatment i was suffering from anxiety and depression.For 2 months after treatment, i had severe headaches.The headaches have since gone away.However, my depression and anxiety are more extreme.I have suicidal thoughts every single day- which i did not have prior to the tms treatments.To date, i have not been able to get relief.I have tried about a dozen anti-depressants and none help.At the time of treatment i was on lay off from my job due to the pandemic.I returned to work in (b)(6) 2021 but had to take medical leave the next month because it was extremely difficult to get through the work day due to my symptoms.I am now on temporary disability from my job that i love and miss.Tms has destroyed my life.I barely leave my home, i am afraid to drive, i don't shower for days.I am a shell of the man i was before the treatment.The tms folks say that there are no major side effects associated with the treatment.But what i am going through are major side effects with no relief in sight.I get angry easily now and i was never an angry person.My cognitive abilities have decreased.I get brain zaps at times.I have twitches in my legs.It is hard for me to stay still.I have very little appetite these days and i have suffered major weight loss.I firmly believe that tms is at fault.This treatment should not be on the market.It gave me false hope.Please investigate.I fear that tms has given me a brain condition and i will never be the same.Fda safety report id# (b)(4).

• Brand Name: NEUROSTAR TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15283600
• MDR Text Key: 298493400
• Report Number: MW5111690
• Device Sequence Number: 1
• Product Code: OBP
• 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: 08/22/2022

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
• Patient Sequence Number: 1
• Treatment: B-12; CURRENT MAGNESIUM; LORAZEPAM AS NEEDED FOR EXTREME ANXIETY.; OMEGA 3; VITAMIN D
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White