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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Anxiety (2328); Cognitive Changes (2551)

Event Date 08/14/2020

Event Type  Injury  

Event Description

I was urged by my psychiatrist at the time to try tms (transcranial magnetic stimulation) therapy for treatment-resistant major depressive disorder (mdd).After an assessment, i was scheduled for 30+ daily treatments of tms therapy.On the first day of treatment, i advised the medical assistant and psychiatrist that it was causing me pain when the therapy was occurring.They decided to lower the intensity, but advised me that i would need to have the intensity level gradually increased in order for the therapy to be effective.By the 4th day of treatment, i noticed that i was having headaches everyday after treatment, and that i was having increased anxiety.I was told that these are normal side effects that will probably go away.The days following my 5th treatment (2 weekend days, and most of monday, when i did not have any tms treatment) i noticed significant changes.I felt dizzy and mentally "spacey".The most significant and noticeable symptom was cognitive and memory impairment, especially my short term memory.I could hardly think straight, and was forgetting everything left and right.This continued through my workday on monday, and i ended up leaving work early that day because i couldn't do any of my work duties in this state.Later that day when i went to my appointment for my 6th tms treatment, i informed the medical assistant and psychiatrist that i did not want to receive tms therapy any longer, and explained the cognitive and memory issues i was having.They acted surprised, and claimed they had not had any other patients report this issue.They agreed with my decision to stop tms therapy, but provided me no advice or guidance on how to deal with these cognitive/memory issues.I returned to my regular psychiatrist who gave me a referral to a neurologist, but advised me that there weren't any tests that would visibly show brain damage or signs of the memory issues i was having.I felt discouraged by this, and never followed up with the referral (and i was never called by the neurology office either).To this day (b)(6) 2022 i am still experiencing impairment to my short and long-term memory, as well as cognitive functioning.I would say that i have recovered only about 80% over the past 2 years.Fda safety report id # (b)(4).

• Brand Name: TMS MACHINE NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15077449
• MDR Text Key: 296408582
• Report Number: MW5111018
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: DAILY MULTIVITAMIN; LAMICTAL; LISINOPRIL; PRISTIQ; VITAMIN D
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White