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

Model Number SYSTEM IV

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

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Visual Impairment (2138); Depression (2361); Disability (2371); No Code Available (3191)

Event Date 01/10/2018

Event Type  Injury  

Event Description

Severe memory loss, short term and long term.The closer to the ect memory is like a blackhole.Problems forming new memories, balance problems, have become very clumsy and frequently do things, speech problems, developed a stutter, accent changed, language problems, disability, problems reading and writing, headaches, vision worsening, night time vision terrible, dissociation, worsening depression, interpersonal problems.Personality disturbances, don't feel human connection, lack of empathy, makes it hard to have friends and get along with other people.I used to write and am now barely coherent in my speech.Fda safety report id# (b)(4).

• Brand Name: THYMATRON
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): SOMATICS, LLC
• MDR Report Key: 9934302
• MDR Text Key: 187056303
• Report Number: MW5094073
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Disability
• Patient Age: 27 YR
• Patient Weight: 82