MAUDE Adverse Event Report: SOMATICS LLC SOMATICS THYMATRON SYSTEM IV ; DEVICE, ELECTROCONVULSIVE THERAPY

Model Number SYSTEM IV

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

Patient Problems Hair Loss (1877); Memory Loss/Impairment (1958); Scarring (2061); Skin Irritation (2076); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 01/01/2017

Event Type  Injury  

Event Description

I was admitted to hosp for depression, medicated heavily, was administered 12 ect sessions without knowing of any permanent effects, don't remember signing consent forms.Almost 3 yrs later, i am experiencing severe retrograde and anterograde amnesia up to 20 years or more, and see a cognitive psychologist on a regular basis.I have breakouts at the location of the electrodes used on my head.I have lost most of my hair after the ect and still am losing it.I have had dental work to repair cracked teeth that my dentist verified was caused by severe clenching.I have lost most of my cognitive abilities like performing math, operating a car, cellphone, and laptop.I have severe focusing difficulties and decision making to the extent of having to write down instructions for myself every hour.I get lost if i drive my car, and can no longer cook.I get lost at grocery stores, and i cannot shop, even with a list.I get very foggy and confused and cannot follow conversations.I can no longer take care of my farm animals, and had to get rid of all of them.I have a volunteer who brings my food.I can no longer run my farm, i had to sell all my equipment, and will have to sell my home.Neuropsychiatrist administered an iq evaluation after the ect and i failed on every level.Mri of the brain in 2018 or 2019 shows temporal and parietal scarring after the ect.Fda safety report id# (b)(4).

• Brand Name: SOMATICS THYMATRON SYSTEM IV
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): SOMATICS LLC
• MDR Report Key: 9883226
• MDR Text Key: 185244166
• Report Number: MW5093935
• Device Sequence Number: 1
• Product Code: GXC
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM IV
• Device Catalogue Number: EDIV
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 73