MAUDE Adverse Event Report: SOMATICS LLC SOMATICS 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); Nausea (1970); Pain (1994); Vomiting (2144); Neck Pain (2433); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Trying to get with symptoms of cervical and lumbar radiculopathy and dystonia since very young.Was misdiagnosed with schizophrenic by psychiatrist.I got psychiatrists.I got serotonin syndrome from drugs that were prescribed.The psychiatrist told me i have no other treatment left beside e.C.T.And was giving 22 e.C.T.Treatments in 45 days.Treatment are extremely painful to the head and neck.Extreme headaches and pain through head.Short term memory loss after 2 treatments.Extreme mental confusion and loss of memory.Experience nausea and vomiting.Symptoms continually getting with every treatment.As treatments continue memory and functionally become almost impossible.The thought process is very completely broken.Relearning how to think is what's next.Relearn how to drive.Feels like you got hit in head with sledge hammer.A lot of brain damage is very possible.Extreme pain in head and neck.Hands and legs went numb.Couldn't move head left or right.Had a lot of physical therapy to regain motion in neck.Fda safety report id # (b)(4).

• Brand Name: SOMATICS THYMATRON
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): SOMATICS LLC
• MDR Report Key: 9888406
• MDR Text Key: 185481096
• Report Number: MW5093944
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYSTEM IV
• Device Catalogue Number: EDIV
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 77