| Device Problem
Unexpected Therapeutic Results (1631)
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| Patient Problems
Headache (1880); Undesired Nerve Stimulation (1980); Twitching (2172)
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| Event Date 07/01/2019 |
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Event Type
Injury
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Event Description
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I had tms therapy for several months 2017-2018.During the treatment the nerves in my hands and around my eyes would jump frequently.The frequency was adjusted, lowered, then raised again.I only did this treatment because my dr said it would help me.It hasn't.A few months ago i noticed that my fingers would jump on its own.The same one in the office that they always messed with using nerves in my brain.Then the one on the other hand.My husband started to notice my whole hand twitching, then i did.In the morning now, i'm completely unable to pen my hands for a few mins.My right eye would still twitch every so often as if those same nerves are being tapped at and a headache would follow.The worst part about the treatment was watching my fingers jump for several mins without me controlling them and i had to convince myself i was doing it to better myself.But sometimes dr (b)(6) didn't like my hands jumping too much, so she would adjust the machine around on my head.Sometimes she would get it to where my hands didn't move at all, other times i wasn't so lucky.In the beginning of the therapy, i was in the room by myself.But the office hired extra help then i was accompanied in the room by (b)(6).Which was great because i was on a machine unable to move or call the dr, so she was able to do that on several occasions to stop the machine when i sneezed once and it slid and my face and hands went out of control.If she wasn't there, i would have been stuck on that machine, brain probably trying.What led me most to reporting this is my hands.They are the worst.I did my tims treatment at (b)(6) center with (b)(6).Fda safety report id# (b)(4).
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Event Description
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Additional information received from reporter on 06/23/2020 for report mw5089990.This problem is progressing since i last wrote my complaint to you.I now identify the tms therapy as the main and only reason for my recurring memory loss and severe headaches.It started slowly after i stopped the therapy, and now i've pinpointed it all back to that therapy.At times my motor threshold was increased to rapidly which caused my eyes to twitch and fingers to jump uncontrollably.That's all connected to nerves inside my brain.I was guaranteed that this was a safe therapy, and no side effects.Now i can't even remember things from my childhood.I have no memories of my little brother.I called him and asked him to tell me stories of us when we were kids.It's like the things he say to me are the lives of others.It triggers no memories of mine.And he literally cried because it hurt him.It's like someone is stealing memories from me, wiping them clean out of my head.Whatever that machine did to my brain by tapping on it over and over and over, it destroyed something important i needed in there.I'm not even sure how you can fix that after weeks of a machine tapping at your brain with electricity.I have wrote you before, and all you sent me was a letter acknowledging you got my complaint.Well what do you do about it? this is a very serious and severe side effect from tms therapy.And my 2nd complaint to you.Don't just let me know you got it, do something about it before it's too late for somebody else.This tms must have not went through clinical trials that long, or given a patient enough time to see the side effects that would develop.Maybe some people are even unaware of what they are experiencing and just categorize it under stress.And remember the people that go in for this treatment usually have some type of mental illness, so if they are telling their doctor they are having memory loss, doctors usually say it's from depression or something instead of actually listening to the patient.So things like this will go un-noticed for awhile until someone sheds some light on it.The tms is dangerous, it has ruined my life! i now have to see a neurologist for migraines and a therapist to deal with my memory loss.Fda safety report id# (b)(4).
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Event Description
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Additional information received from reporter on 11/16/2020 for report mw5089990.I'm not sure if the date above is correct.I've written you several reports and no one have followed up with me.Just a generic letter is what i've received.I do have the dates when i started tms therapy in my records and i have sent it to you with the previous report.I just can't remember at the moment.I was harmed by tms therapy.My symptoms are getting worse.I was tested by my neurologist and my nerve damage is getting worse.Some of my nerves doesn't have any sensation, and the emg couldn't pick up any signs of nerve function in my right leg.Same side i was having the majority of my issues.My migraines are getting worse and i had to start a new medication to basically keep my head from exploding, and my short and long term memory is declining.I'm only (b)(6) yrs old.Too young to be experiencing so many issues.Before tms, i had none of these issues.I don't believe that this type of therapy is safe, and needs to be pulled off the market as safe.Or give any future patients the real side effects that so many people are dealing with after tms.A basic (b)(6) search won't give you the horror stories of people just like me and worse.You have to find them in support groups, (b)(6) and (b)(6) groups.The internet make tms feel like a cure for the mental afflictions that i the victims face, but in fact it's our worse nightmare.The truth needs to get out.Fda safety report id # (b)(4).
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Search Alerts/Recalls
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