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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Anxiety (2328)

Event Date 10/06/2022

Event Type  Injury  

Event Description

I have received 8 tms treatments for my severe anxiety and panic.I also have vestibular migraines.I had six treatments on the left side and two treatments on the right.I know it is only approved for depression.But two neurologists and two psychiatrists thought it would help with my anxiety.They were wrong.I have had increased anxiety and worsening migraines.There needs to be greater oversight of using tms.It is being promoted for just about any mental health condition.Tonight i am wondering what it has done to my very fragile mental state.Tms has had many complaints on various social media pages.There needs to be greater oversight of the use of this potentially dangerous treatment.Fda safety report id# (b)(4).

• Brand Name: TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15595839
• MDR Text Key: 301856186
• Report Number: MW5112585
• 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: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: CRESTOR; DIAZEPAM; IBUPROFEN ; LOSARTAN ; METOPROLOL ; MIRTAZIPINE; NABUMETONE; TYLENOL ; ZOFRAN
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White