MAUDE Adverse Event Report: ECT; DEVICE, ELECTROCONVULSIVE THERAPY

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/01/2019

Event Type  Injury  

Event Description

I endured 9 lbs of electroconvulsive therapy from 2010 to 2011.I had over a year of intense recovery and still have difficulty.I reported problems to my dr many times, no one believed that ect could have caused it.Now i believe i was correct.My best friend said the year after my last round was horrible and she didn't think i would recover as well as i have, but i am far from normal.(b)(6).Fda safety report id# (b)(4).

• Brand Name: ECT
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 9317939
• MDR Text Key: 166741318
• Report Number: MW5091068
• 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: 11/07/2019
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 66