MAUDE Adverse Event Report: BRAINSWAY LTD. BRAINWAY TRANSCRANIAL MAGNETIC STIMULATION; TRANSCRANIAL MAGNETIC STIMULATOR

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Brain Injury (2219); Anxiety (2328); Depression (2361); Cognitive Changes (2551); Speech Disorder (4415); Unspecified Nervous System Problem (4426); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 05/01/2023

Event Type  Injury  

Event Description

I had transcranial magnetic stimulation from (b)(6) 2023.I did the full treatment of 36 treatments, 5 days a week.It has left me severely brain damaged.I was barely monitored throughout the whole course and i complained about heightened anxiety the whole entire time.The technician and doctor did not do anything about this, except lower the voltage a little bit half way through and told me to keep going.I started showing symptoms of brain damage in (b)(6) 2023.I now have memory loss, aphasia, cognitive impairment, extreme high level anxiety, suicidal ideation, severe depression, chronic fatigue, derealization, an over active nervous system and my psychological issues that i was being treated for are even worse than before.Thousands of people are being severely injured without being informed of the severe side affects that has been done to me.That choice is being taken from without being told the moment that machine is being put on their head.

• Brand Name: BRAINWAY TRANSCRANIAL MAGNETIC STIMULATION
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): BRAINSWAY LTD.
• MDR Report Key: 19086528
• MDR Text Key: 339889660
• Report Number: MW5153681
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DEPAKOTE
• Patient Outcome(s): Other; Disability; Required Intervention; Life Threatening
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White