MAUDE Adverse Event Report: MAGVENTURE INC. / MAGVENTURE A/S TRANSCRANIAL MAGNETIC STIMULATION - TMS MAGVENTURE DEVICE; TRANSCRANIAL MAGNETIC STIMULATOR

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Paralysis (1997); Tinnitus (2103); Dizziness (2194); Anxiety (2328); Malaise (2359); Depression (2361); Irritability (2421); Neck Pain (2433); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Suicidal Ideation (4429); Cramp(s) /Muscle Spasm(s) (4521); Increased Sensitivity (4538); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 i started my tms tbs treatments with the magventure device at (b)(6) medical center.During my treatments my right leg would involuntarily spasm and jump off of the chair and sometimes the left side of my face would seize up.Then i'd feel woozy and lightheaded at the end of the tms sessions.I got up to the 110% intensity.Then the migraines started (my baseline migraines had been less frequent as well as less in intensity and the migraines i had experienced post tms treatment were severe and not like any of the migraines i had been experiencing recently;) and the sleep paralysis, my mind was awake and racing but my body wouldn't or couldn't move and the 1 nightmare/dysphoric dream and then tossing and turning.Session 2: then after my 2nd session i experienced irritability and agitation as well as increased anxiety and si(suicidal ideation).Then another migraine, neck pain, muscle stiffness fatigue, somnolence, stabbing pain in my right knee.In the middle of the night i tried lifting my right leg to get into bed 3 times but it was as if it was glued to the floor.Worsening tinnitus and neck pain.Malaise.Unsteadiness and some weakness.I was also experiencing sinus/facial pressure, watery eyes, runny nose.I told the nurse administering my third session that i felt like he wasn't listening to me and like i was being pushed.I stated that i felt the 120% intensity threshold that needed to be met in order for me to feel better was not what my brain needed.2 of the providers were pushing me to get to 120% as quickly as possible or else i wouldn't get better.Session 3: the migraine was almost just more of a headache so that had me feeling hopeful; but when it came time to sleep i had full blown insomnia, i just tossed and turned for 5 hours and didn't get any actual proper sleep/rest.Every time i had a tms treatment, my sleep was negatively impacted.In my chart the psychiatrist wrote: "i explained to [patient] the common side effects from tms including headaches, scalp and facial pain, facial twitching, decreased hearing, tinnitus, dizziness/lightheadedness, nausea, and tiredness.I explained her that agitation/irritability or si were not common side effects." he did no such thing.He said to me that i wasn't experiencing side effects and what i was experiencing was probably from something else like recent stress or my ptsd.He did mention to me that my headache was probably a side effect and that they would probably to decrease as treatment advances.He will be reported to the state in which he practices for misconduct.I experienced another severe migraine on (b)(6) and more anxiety and panic and nausea and tinnitus and weird sensations like worsening adhd, time blindness, confusion, brain fog, inability of focus.I felt cognitively impaired, like my vision is a bit off (increased photosensitivity and newly appeared eye floaters) and as if my anxiety, depression and adhd are actually worse.Oh and my loss of appetite and nausea/queasiness.Tooth sensitivity.Forgetful too.I feel like i keep repeating myself or i can't remember things.This is horrifying.And retraumatizing which, of course, is causing my ptsd symptoms to worsen as well.

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATION - TMS MAGVENTURE DEVICE
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): MAGVENTURE INC. / MAGVENTURE A/S
• MDR Report Key: 17558985
• MDR Text Key: 321281340
• Report Number: MW5144605
• Device Sequence Number: 1
• Product Code: OBP
• Combination Product (y/n): N
• 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: 08/14/2023

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: 08/16/2023
• Patient Sequence Number: 1
• Treatment: CETIRIZINE PRN; IBUPROFEN; MULTIVITAMINS; SPIRONALACTONE; TUMERIC; TYLENOL; VITAMIN D
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White