MAUDE Adverse Event Report: TMS MACHINE

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/02/2016

Event Type  Injury  

Event Description

I was getting transcranial magnetic stimulation (tms), which is supposed to be a virtually painless procedure, from the technician.She did not place the device correctly on my head and caused severe pain through my ear, jaw, and teeth.I screamed in pain, but she didn't immediately stop the machine.She stood there and just looked at me like she didn't know what to do.Then she went to the machine (doing what, i don't know), but it happened for a second time.I screamed in pain again and got out of the chair as quickly as possible and told her to get the doctor.She said he had already been called earlier.Why? i'm not sure, but i think it was because she wasn't sure where to place the device on my head and needed assistance, but instead of waiting for help, she went ahead and performed the procedure anyway.The technician is not thoroughly trained in using this equipment and lacks common sense and maturity to perform this on pts.I asked about her eduction and she told me she was a receptionist in the office and got "promoted" to tms technician.Where is her degree in psychiatry, phd in psychology, lcsw license, or even psychiatric technician certificate? shouldn't people who are messing with your brain have some schooling to basic physiology, biology, and psychology? she caused me to scream out in pain and was indifferent to the fact she was causing the pain.Neither she, nor anyone else, should be allowed to perform tms on pts without having some sort of degree in phycology and an understanding of the function of the brain.I desperately need this treatment, but now i'm afraid.I told the doctor what happened, but he is not the owner of the business and states he can only advise the owner what happened, but can't do anything about it.Of course the owner is his boss.Another technician was scheduled to see me the next day so i went in.He down-played the significant pain that the other tech had caused me.My concern is that there are technicians who are not fully trained and educated in the human brain and are not qualified to treat pts with the tms device.Furthermore, there seems to be no concern by the doctors at this office that the staff is not adequately qualified to perform this procedure on pts.I pray that this does not happen to anyone else; or maybe it already has.It's been two days since my treatment and my jaw and teeth still ache from what that technician did.Also, i don't believe there are any studies done that indicate the damage that can be caused to other parts of the brain when this device is used by an untrained, uneducated person.The indifference of the doctors is also disconcerting and i don't expect to get a resolution from them.I've read the fda's guidelines on tms; however, it appears vague in the area of the training and education required to use the tms machine.It did state that the "clinician" will.I don't see any reference to using a technician or receptionist to practice on pts.

• Brand Name: TMS MACHINE
• Type of Device: TMS MACHINE
• MDR Report Key: 5636754
• MDR Text Key: 44725694
• Report Number: MW5062132
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR