MAUDE Adverse Event Report: TRANSCRANIAL MAGNETIC STIMULATION; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Pain (1994); Suicidal Ideation (4429)

Event Date 06/16/2021

Event Type  Injury  

Event Description

I was told by dr (b)(6) that i was a great candidate for tms treatments.She told me treatments were not painful, just a minor discomfort.The treatments were actually extremely painful.They hurt so bad i was crying and did not want to complete the program at all.She talked me into staying and lowered the intensity of the magnets very low.So low that by the time my treatments ran out, i was finally at the full percentage.Each week i filled out a form and expressed no improvements in moods with the treatments.Nothing was ever mentioned to me about not making any improvements.When i asked if they could work with me on what i owe bc the treatments did not work as dr (b)(6) promised, they said no.My therapist told me that i needed to go to the hospital.My therapist actually ended up dropping me as a patient because i decided to do the tms treatments instead of going to the hospital.My therapist said i was "too much of a liability." (i decided tms because dr (b)(6) was very convincing in how this treatment was right for me and better than medication/hospitals) after these treatments not working, losing my therapist because i believed dr (b)(6), and still having to pay for the treatments that didn't work like promised, it has caused me to be even more depressed, self harm myself and attempt suicide on more than one occasion.It has also caused me to feel like a failure.I think i had 6 weeks of treatments.Total cost almost (b)(6).(b)(6).Fda safety report id# (b)(4).

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATION
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• MDR Report Key: 12475391
• MDR Text Key: 271511687
• Report Number: MW5103953
• Device Sequence Number: 1
• Product Code: OBP
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 36 YR
• Patient Weight: 43