MAUDE Adverse Event Report: NEURONETICS INC. TMS TRANSMAGNETIC CRANIAL STIMULATION DEVICE NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Skin Discoloration (2074); Tinnitus (2103); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Eye / Vision Problem (4471)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Dr (b)(6) told me neurostar tms (transmagnetic cranial stimulation) was side effect free other than possible headache the first 3 treatments.Before the "treatment" i was told i could listen to my earbuds if i felt like it but just to try not to fall asleep.The tech said they're inducing a seizure in me first thing to get my "baseline".This should have been my warning sign but dr (b)(6) said there's a 67% chance i'll never need psychiatry again.After the treatment which was similar to a jackhammer operated 1/4" from my head, i immediately developed the worst headache of my life which would last weeks.They convinced me that horrible side effects were normal and i endured 3 "treatments." my skin darkened at the site of the tms probe.I developed ringing my ears which never was an issue before.Light and sound became painful permanently.I spent 2 weeks sleeping with a towel over my eyes.I'm writing this almost 4 years later and i have not improved.Dr (b)(6) gaslighted me and claimed "earplugs were offered" also that it's impossible his "safe tms machine" caused this.He claimed nobody else had ever had any side effect from tms.I've had mental effects that impact my ability to work and socialize.I've had to change the type of work i do and limit social events involving light or noise.Watching a movie my tms-ptsd is triggered with reverberating sounds like helicopter noises.Believing this psychiatrist and doing tms was the worst decision i've ever made.Researching tms i discovered that many people have had these same traumatic brain injury symptoms.Fda safety report id# (b)(4).

• Brand Name: TMS TRANSMAGNETIC CRANIAL STIMULATION DEVICE NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 14084843
• MDR Text Key: 289220290
• Report Number: MW5108910
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White