MAUDE Adverse Event Report: MAGVENTURE A/S / TONICA ELEKTRONIC A/S MAGVENTURE, MAGVITA TMS THERAPY; TRANSCRANIAL MAGNETIC STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Headache (1880); Hearing Loss (1882); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Vomiting (2144); Brain Injury (2219); Sleep Dysfunction (2517); Cognitive Changes (2551); Weight Changes (2607); Increased Sensitivity (4538)

Event Date 12/14/2020

Event Type  Injury  

Event Description

I had one single transcranial stimulation therapy session using a magventure device.The doctor was (b)(6), md, phd.In (b)(6).Dr.(b)(6) has part ownership in the device company.Dr.(b)(6) specifically stated before using the device that, "there are no side effects and no short-long term memory loss".The device was set at 20% intensity for 20 minutes.However, i had severe side effects including (ongoing) cognitive impairment, bilateral tinnitus, loss of short-long term memory, 24/7 headaches, 24/7 brain fog and borderline hearing loss in left ear i'm currently being treated by other doctors for the injury.The brain damage may be permanent.Below are a list of my current symptoms.Tms injury update: on (b)(6) 2020: ate first "meal" since (b)(6) 2020 at 8pm.Second bm on (b)(6) 2020 since (b)(6) 2020 24/7 headache with tinnitus; difficulty functioning.Still experiencing intermittent ear pain.24/7 localized pain on left side of head where device was placed high frequency tones/loud sounds unbearable significant difficulty reading and understanding written text nausea partially subsided on (b)(6) 2020 enough to eat something, no more vomiting lost at least 5 pounds since (b)(6) 2020 (pants are very loose) experiencing classic tbi symptomatology including bouts of anger, behavior changes and insomnia continued loss of: short and long-term memory, critical thinking skills, event recall and ability to multitask difficulty/impairment in reading and concentrating, difficulty following and remembering conversations symptoms of chronic fatigue; sleeping significantly more than usual (went to bed at 10:30am last night, woke up at 8:30am (10 hours of sleep), i generally wake up after 8 hours of sleep religiously (generally early riser and wake up around 6am every day).Headaches and fatigue after verbal communications very sensitive hearing, possible damage to auditory cortex and surrounding structures impaired ability to express emotion and less able/willing to communicate verbally dr.(b)(6) adamantly denied any and all correlations between the medical procedure using his device and negative side effects.Dr.(b)(6) later dropped me as a patient after begging for immediate medical treatment and complaining about severe symptoms.Dr.(b)(6) later stated in a "physician terminating patient care for a challenging patient" letter that "symptoms you reported are not typical or frequent side effects related to this treatment to the best of my knowledge".Fda safety report id # (b)(4).

• Brand Name: MAGVENTURE, MAGVITA TMS THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): MAGVENTURE A/S / TONICA ELEKTRONIC A/S
• MDR Report Key: 11087069
• MDR Text Key: 224761992
• Report Number: MW5098553
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR
• Patient Weight: 77