SOMATICS 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 2020-03-25 for SOMATICS THYMATRON SYSTEM IV EDIV manufactured by Somatics Llc.

Event Text Entries

[185244166] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093935
• MDR Report Key: 9883226
• Date Received: 2020-03-25
• Date of Report: 2020-03-23
• Date of Event: 2017-01-01
• Date Added to Maude: 2020-03-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SOMATICS THYMATRON SYSTEM IV
• Generic Name: DEVICE, ELECTROCONVULSIVE THERAPY
• Product Code: GXC
• Date Received: 2020-03-25
• Model Number: SYSTEM IV
• Catalog Number: EDIV
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SOMATICS LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2020-03-25