THYMATRON SYSTEM IV EDIV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for THYMATRON SYSTEM IV EDIV manufactured by Somatics Llc..

Event Text Entries

[185805400] Skin in damage; i went to (b)(6) hospital in (b)(6). I was tired of taking medication for my illness condition and read some articles that ect was a good option for depression, i went to that hospital in person and asked the chief nurse at the front desk if the hospital provide ect, she replied yes and immediately pursued me to stay overnight to have the ect on (b)(6) 2015 meaning two days after my admission. The hospital and neither the doctor asked me for my psychiatrist referral, never asked me my diagnosis, never get my medical history record, doctor (b)(6) never explained about any side effects about the treatment. He just told me that my brain would be brand new and explained the anesthesia consent, before the treatment i never signed any consent to get the treatment, dr (b)(6) just informed that 12 sessions of ect were going to be done. Unfortunately i could not resist the treatment at session number 6, i felt immediately a devastated side effect and right away told dr. (b)(6) to stop the treatment. After 6 sessions of ect my depression got tripled, a few hours after the treatment i notice on my skin red rashes, they never told me why my skin was red and never administrated anything to relief the side effect on my skin. The treatment left me incapacitated due to the horrible deeper depression that i am still facing. In the preliminary interview at the hospital states that i was a functional woman with mild depression and one single episode but ect has tripled the depression symptom that i cant function myself to do my basic daily tasks and after discharge my family looked for a home aid assistance. Ect destroyed my life. Dr. (b)(6) had me hospitalized for 40 days and changed all types of antidepressants and nothing work; the chief nurse told my family that i must required a long term care because they could not have me for a longer period of time and asked my father if he can have the custody for my due that the hospital was deciding to send to a state psychiatric hospital in (b)(6). I complained to dr (b)(6) and the rest of the staff that i felt really suicidal and felt my depression real chronic after the treatment and they ignored my pain and told me to get help somewhere in another hospital because they were not able to help any more. Dr. (b)(6) was really insane, he never explain any type of risk of it, never request my medical record and never believed me when i told him that my depression got worse as a killing painful symptom. Since then i have been isolated in my roof for many years and had many suicidal attempts, antidepressants stopped working in my brain and lost my husband and most frustrate i lost my soul and myself, and all the dark black spot left on my body, they never answered from where my skin was damage. After ect; my left atrial was abnormal, anteroseptal q waves- is consider lead placement- abnormal ecg. Brain test was done with neuro - psychologist dr (b)(6); the diagnoses: left front lobe degeneration (r41. 82), senile of the brain deteriorated (r41. 844) g631. 1. (f33. 3), thalamus field medulla oblongata, brain midfield affected. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093984
MDR Report Key9905310
Date Received2020-03-31
Date of Report2020-03-30
Date of Event2015-10-05
Date Added to Maude2020-03-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Report3

Device Details

Brand NameTHYMATRON
Generic NameDEVICE, ELECTROCONVULSIVE THERAPY
Product CodeGXC
Date Received2020-03-31
Model NumberSYSTEM IV
Catalog NumberEDIV
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSOMATICS LLC.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit 2020-03-31

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