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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION (TMS) SYSTEM; TRANSCRANIAL MAGNETIC STIMULATOR

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NEURONETICS, INC. NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION (TMS) SYSTEM; TRANSCRANIAL MAGNETIC STIMULATOR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Muscle Weakness (1967); Pain (1994); Blurred Vision (2137); Anxiety (2328); Depression (2361); Irritability (2421); Palpitations (2467); Sleep Dysfunction (2517); Weight Changes (2607); Suicidal Ideation (4429)
Event Date 02/01/2020
Event Type  Injury  
Event Description
Went to emergency room; i suffer from anxiety, depression, insomnia and i'm bipolar.I'd been on medicine for 11 years and they didn't work anymore.I was determined to find help for myself without the aid of medication.I found a facility, (b)(6), that administered trans-cranial magnetic stimulation (tms).The full treatment requires 36 sessions.I endured 8 sessions, 3 on the left hemisphere for depression ((b)(6) 2020 (l)).My anxiety was more severe than my depression, so the doctor switched the coil to the right hemisphere for the remaining 5 sessions ((b)(6) 2020 (r)).This was an off-label treatment.The first 2 sessions felt promising, but it went downhill after that.Dr.(b)(6) informed me that it will get worse before it got better so i tried to stick with it.My depression/anxiety/insomnia worsened so severely during these 8 treatments that i had to seek help at (b)(6) on (b)(6) 2020 because i felt like i was losing my mind, literally.I was constantly crying, catastrophizing everything, suicidal ideations (without intent), and i didn't sleep for 4 days.They wanted to admit me but couldn't because they didn't have any beds available.I'm bipolar and i've never experienced a manic episode.The tms induced mania.I managed to get an emergency appointment with a new psychiatrist that helped me.Since tms, i've been experiencing worsened insomnia, terrible fatigue, nervousness, irritability, anxiety, memory loss, cognitive impairment, blurred vision, unintentional weight loss ((b)(6) in 11 months), low libido, gastrointestinal issues, hair loss, heart palpitations and muscle weakness/loss/pain.I now have an impingement syndrome in my right upper arm due to tms which was diagnosed by my orthopedic doctor.I am seeing a neuromuscular doctor on (b)(6) 2021 to address my muscle weakness.There are hundreds, if not thousands, of victims of tms that exhibit the same adverse side effects as me.The document i signed outlining the risks of tms included, painful sensations at the treatment site, possible headaches and possible hearing loss.There were no indications that i would have any other adverse side effects.After treatment, i started digging and found that tms should not be administered on bipolar patients.They should have known this.My side effects mimic so many issues.I went to (b)(6) because i thought i had thyroid abnormalities or cancer (it runs in my family).It's not cancer.The (b)(6) doctor was so puzzled by my symptoms that he recommended that i go to the (b)(6) to be evaluated.I've had an endoscopy, colonoscopy and gastric emptying tests done to address my weight loss.I've seen a neurologist to address my insomnia, cognitive impairment and memory issues.I see a rheumatologist on (b)(6) 2021 to rule out any autoimmune issues.I've seen 2 different endocrinologists to rule out any endocrine issues.I just discovered 3 days ago that tms is purposely used for weight loss and is advertised as such.This explains a lot.This was never disclosed to me.Here i am withering away trying to find help for all of my various symptoms when they all point back to tms.The doctors that administer tms are well aware of the adverse side effects.They are not disclosed because of greed.Tms at (b)(6) costs over (b)(6) for 36 treatments and sufferers, like myself, are so desperate that they will try anything to stop the mental pain.The clinic isn't going to tell a patient that they may develop muscle wasting and memory loss etc.Nobody in their right mind would risk it.Tms doctors are predators.A (b)(6) search will return all positive reviews and testimonials.Of course it does.Censorship is killing us.I had to really dig to find negative reviews and when i found them, it was the biggest "ah hah" moment of my life.I realize tms helps some people, but all of the side effects need to be disclosed.All victims of tms that i have conversed with all say their memory and cognitive tests come back normal, even with eegs, yet we still exhibit both of these unexplainable problems.It's a different kind of memory loss and cognitive issue.It's difficult to explain and understand.I'm having to relearn things where i work.I'm a computer programmer and have been for 23 years.I don't recognize code that i've written 2-3 years ago.This is alarming because a programmers' code is unique to each of us and it's like a signature.It's causing me a lot of problems at work.Almost like i'm a new hire.I must walk around with paper and notepad to take notes just in case someone catches me in the hallway to discuss work.I take pictures and text messages of anything that i feel is important to refer to in the future because i can't remember.I will watch an episode of a tv show and get 3/4 of the way through it before i realized i had already watched it the week prior.Thankfully, my thyroid nodule is not cancerous but will be carefully tracked in the future due to family history.I'm still working with my psychiatrist to figure out what to do about my insomnia.Before tms, i would go the gym 3 times per week, and i ate healthy.After tms, i am so fatigued, and my muscles are so weak that i cannot go anymore.I haven't been in over a year.I also eat whatever i want, and the weight keeps falling off.I'm also working with a neuromuscular doctor to figure out what's going on with my muscles.The doctor is referring me to her sleep specialist, physical therapy for my arm and sending me to have a neuropsychic test.I've never experienced these symptoms prior to tms.I need help.I'm doing everything i can and being proactive but not 1 doctor can put the pieces together.Tms may have been fda approved in 2008 for left hemisphere/major depressive disorder, but it's so new in my area that doctors don't have any experience with it or its negative side effects.Fda safety report id# (b)(4).
 
Event Description
Additional info received from reporter on 03/01/2021 for mw5099368, reporter advised, she was not on the following medications: temazepam, gabapentin, lithium and hydrocodone during the time of treatment using trans cranial magnetic stimulation.
 
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Brand Name
NEUROSTAR TRANSCRANIAL MAGNETIC STIMULATION (TMS) SYSTEM
Type of Device
TRANSCRANIAL MAGNETIC STIMULATOR
Manufacturer (Section D)
NEURONETICS, INC.
MDR Report Key11322003
MDR Text Key231634205
Report NumberMW5099368
Device Sequence Number1
Product Code OBP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/01/2021
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ALLERGY INJECTIONS 1 SHOT IN EACH LEG WEEKLY ; ATORVASTATIN 10 MG TABLET TAKE 1 TABLET EVERY DAY ; DAILY VITAMIN ; GABAPENTIN CAP 100 MG ; HYDROCODONE ACETAMENOPHIN 5-325 MG PER TABLET, 1 TABLET EVERY 6 (SIX) HOURS AS NEEDED FOR MODERATE PAIN FOR NON-ACUTE PAIN ; LEVOCETIRIZINE TAB 5 MG ; TAKE 1 CAPSULE IN THE MORNING OLMESARTAN TAB 10 MG ; TAKE 1 CAPSULE IN THE MORNING TAKE 2 CAPSULES IN THE EVENING FLONASE AS NEEDED; TAKE 1 TABLET EVERY DAY FISH OIL ; TAKE 1 TABLET EVERY DAY LITHIUM CARB CAP 300 MG ; TAKE 1 TABLET EVERY DAY MONTELUKAST TAB 10 MG ; TAKE 1 TABLET EVERY DAY PANTOPRAZOLE TAB 40 MG ; TEMAZEPAM 15 MG CAPSULE TAKE 1 CAPSULE (15 MG TOTAL) NIGHTLY AS NEEDED FOR SLEEP
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age42 YR
Patient Weight70
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