MAUDE Adverse Event Report: ECT MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY

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

Patient Problem Brain Injury (2219)

Event Date 11/22/2001

Event Type  Injury  

Event Description

I got ect or shock treatment and no one warned me about it causing a traumatic brain injury.It took me 2 years to heal from hat brain injury.Mental health stuff is hard enough without adding a brain injury on top of it.Fda safety report id # (b)(4).

• Brand Name: ECT MACHINE
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 8739975
• MDR Text Key: 149621091
• Report Number: MW5087665
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 27 YR
• Patient Weight: 68