TRANSCRANIAL MAGNETIC STIMULATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-26 for TRANSCRANIAL MAGNETIC STIMULATION manufactured by Neuronetics Inc..

Event Text Entries

[98580647] This is transcranial magnetic stimulation. A device made by neurostar. The fda approved this in 2008. It used powerful magnets supposedly to relieve depression. Once supposed to do about 30 sessions 5 days a week for about 35 minutes. As it's supposed to build up and not take effect until about end second to beginning third week, all research list the side effects as mild scalp irritation, eye pain muscle twitch pain of the skin, and a 0. 1 percent of a seizure. That's it. Instead, it made me sick during the treatment, nausea, dizziness, felt like going to pass out at night and i did the treatment in the mornings. By the third week i woke up in the middle of the night to go to the bathroom and i felt like i was going to die. I had such a sickly feeling inside my head and body. Then my body started to hurt all over. At the time i didn't know why. I stopped at the 20ths session as of the 19th session i started to feel activated and by the 20th session when i went home to go to sleep i felt wired like i was on speed but had no drugs in me. I could not sleep at all. It took benzodiazepines to help sleep but it did nothing. Before tms if i had a bad night they would make me sleep. Now after tms they did nothing. Why? I went almost 2 weeks on 2-1 hours sleep a night. I had such pain all over my body inside i thought my life was over until i saw a neurologist who gave me an ambien, i slept and the pain lessened. However i had such a hangover, i finally got to see a psychiatrist who put me on powerful zyprexa. Mind you i had not been on any medication for 2 years and none during tms treatment. I gained 55 lbs and became just a zombie. I researched for months if tms can cause terrible insomnia. Even on neurostars website it says, does not cause insomnia. Six months later it found a dr perera in connecticut who was on the dr oz tv show years earlier promoting tms. He told me i got a rare side effect of switching into mania or mixed state. When one gets that they cannot fall or stay asleep. But how can this be, it says on neurostars website does not cause insomnia. Well it did and i suffered so much pain from it. It's now 2 years later, i had to come off the zyprexa due to huge weight gain of almost 60 lbs and was switched to other meds. I wake up every morning with pain all over my body it hurts so much. This started the 2nd week of tms. The zyprexa helped that pain. My point is, i never had pain all over my body in my life until i did tms. It's now 2 years later. I'm on disability and can hardly move and suffer every single day with pain and extreme depression that didn't exist before tms. One can have the flu and have a low grade fever let's say of 100. 5. But one can also have 105 fever. That's what tms did. I went from the low grade fever to having 105 every single day. I can't stop meds as the pain is just too much. I can hardly move most days. This device is dangerous. The changes it makes to the brain are permanent. They don't go away. I was a working father before tms. Now i just sit home in pain on disability. No one is held responsible for this. I want some action taken regarding this tms. It's dangerous. I'm not the only one. In the last two years there are a lot of reviews on tms. People are reporting and much worsening of depression than before tms and have no answers. This is a powerful magnet that's changing brain chemistry and if it goes wrong you're screwed for life. I've lost my life i once had because of tms. This is my third time writing this and nothing has been done. No one has called back or emailed me or any response. This should be taken off the marketplace. It's dangerous and harmful. I've lost everything because of this treatment and i'm in pain every single day because of it. Neurostar who is just one manufacturer only promotes the positives of this treatment. There's a lot of negative for this treatment. Ref report numbers mw5067012 and mw5072838.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074918
MDR Report Key7224481
Date Received2018-01-26
Date of Report2018-01-25
Date of Event2016-01-28
Date Added to Maude2018-01-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTRANSCRANIAL MAGNETIC STIMULATION
Generic NameTRANSCRANIAL MAGNETIC STIMULATION
Product CodeOBP
Date Received2018-01-26
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNEURONETICS INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2018-01-26

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