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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Headache (1880); Nausea (1970); Irritability (2421)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Since tms therapy i have had extreme irritability.I had really bad nausea and headaches after my first treatment and it lasted for months.I have never had motion sickness before but when i was on my way home from tms session i had extreme motion sickness and i have driven over 250,000 miles in my life and even 30 hours straight across the country with no issues, so i am concerned if tms caused this, the motion sickness i'm still very susceptible to, and playing video games after about 10 minutes i am taking over the counter medication for nausea.I feel like dopamine and dopamine receptors are just gone completely, not even the slightest joy in anything anymore.I would like to know if anyone else has experienced this and know if this treatment did do any significant damage to my brain.Fda safety report id# (b)(4).

• Brand Name: NEUROSTAR CHAIR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15003613
• MDR Text Key: 295900055
• Report Number: MW5110833
• 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: 07/09/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male
• Patient Weight: 11 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White