MAUDE Adverse Event Report: ECT MACHINE; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B

Patient Problems Memory Loss/Impairment (1958); Brain Injury (2219); Cognitive Changes (2551)

Event Date 02/04/2024

Event Type  Injury  

Event Description

I am reporting this date but received the treatment over a period prior to this.I had over 50 bilateral ect treatments over a period of time and receiving them times per week.I was left with sever brain damage memory loss and loss of function.My family records this as beginning shortly after i initially started treatment but were told it was temporary and goes away.I have entire years of my life surrounding prior to and since that are just missing.I wasn't able to even know how badly i was affected until a few weeks ago when discovered some old journals i had kept.

• Brand Name: ECT MACHINE
• Type of Device: ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B
• MDR Report Key: 18667940
• MDR Text Key: 335022800
• Report Number: MW5151178
• Device Sequence Number: 1
• Product Code: QGH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White