MAUDE Adverse Event Report: TMS (TRANSCRANIAL MAGNETIC STIMULATION); TRANSCRANIAL MAGNETIC STIMULATOR

Patient Problems Bradycardia (1751); Headache (1880); Pain (1994); Brain Injury (2219); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 08/01/2023

Event Type  Injury  

Event Description

Patient called to report an adverse event involving tms (transcranial magnetic stimulation) treatment she received in the beginning of (b)(6) 2023.Patient stated she was told the device was being used to treat major depression, but she said she never had depression, she suffered from ptsd (post traumatic stress disorder), brain injury, anxiety, and insomnia.Patient stated she was told the tms device treatments would help her symptoms and started a 6 week round of 30 treatments in (b)(6) 2023.Patient stated the treatments were extremely harsh and described them as feeling like a hammer was banging on her head.Patient stated that although she experienced anxiety from her ptsd, she did not expect the device to remove the ability to feel anxious completely.Patient stated she is now a hypersomniac with a drop in heart rate, she could sleep all day, has a constant headache, and major memory problems.Patient said she can¿t remember anything it¿s like she has dementia, and she can¿t find anything.She stated the device was supposed to help with her constant state of fight or flight not completely wipe it out.She said she can no longer go to the gym and that her body feels depressed all day.Patient stated she was not depressed before the treatment, but now after the treatment she feels depressed and broken from the brain damage and head pain it¿s caused her.She stated her brain is not working or functioning at all and she constantly loses her train of thought.Patient said she called the treatment center to question her side effects and was told a second round of 22 treatments on a different tms machine could help so she started another round in (b)(6) 2024.She said she eventually just stopped the treatments as it was doing more harm than good for her.Patient stated she believes the second round of treatment really caused the head pain to become worse and she described it as feeling like her brain is bruised.Patient stated the tms treatments have completely ruined her life and she¿s left feeling permanently broken.She said she still suffers from insomnia and that nobody from the clinic ever followed up with her after her treatments.Reference report mw5153901.

• Brand Name: TMS (TRANSCRANIAL MAGNETIC STIMULATION)
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• MDR Report Key: 19125695
• MDR Text Key: 340468479
• Report Number: MW5153902
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Sex: Female