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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECT; DEVICE, ELECTROCONVULSIVE THERAPY
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ECT; DEVICE, ELECTROCONVULSIVE THERAPY Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 11/01/2019
Type of Reportable Event Serious Injury
Event or Problem 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).
 
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Brand Name
ECT
Common Device Name
DEVICE, ELECTROCONVULSIVE THERAPY
MDR Report Key9317939
Report NumberMW5091068
Device Sequence Number2050825
Product Code GXC
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/12/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age52 YR
Patient Weight66
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