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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Pain (1994); Seizures (2063); Anxiety (2328); Arthralgia (2355); Suicidal Ideation (4429)

Event Date 09/11/2020

Event Type  Injury  

Event Description

Tms was performed by a doctor who apparently was not licensed to administer neurostar tms.I explained prior to treatment mapping that i had a brain injury.Doctor also knew i was not taking an antidepressant but called one in and said not to pick it up at pharmacy.After 4 or 5, treatments i began having seizures and was suicidal, yet doctor belittled me and would not report to neurostar or stop treatments.I was suicidal.I have multiple trips to hospitals.Severe muscle and joint pain, migraines, psychosis and major anxiety.No one was listening.My neurologist would not do an eeg because i had tms.Doctors know nothing and im in (b)(6).Please help i'm seeking attorneys as i cannot work or take care of myself.Stop tms.More care is needed during and after treatments.People are dying from suicide number mental health matters.Fda safety report id # (b)(4).

• Brand Name: NEUROSTAR TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 11258480
• MDR Text Key: 229625494
• Report Number: MW5099098
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): Y
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 73