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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELECTROCONVULSIVE TREATMENT MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY
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ELECTROCONVULSIVE TREATMENT MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Depression (2361); Disability (2371)
Event Date 02/13/1987
Event Type  Injury  
Event Description
At (b)(6) y/o, i was hospitalized for severe depression and given 20 ect treatments over 7 weeks.Prior to ect, i was in the top 1% of my entire class at (b)(6) university.After ect, i returned to school to complete my degree and struggled to finish taking 9 credit hours at a time.I had easily completed 18 to 21 credit hours a semester before ect.I was deemed disabled by (b)(6) rehab when i was (b)(6); permanently disabled by social security when i was (b)(6).Now age (b)(6), i continue to struggle to this day.I lost all memories from several years before ect.I have ongoing symptoms very similar to those reported by veterans with traumatic brain injuries.There was no benefit and much enduring harm caused by ect.My parents were involved with my care and no one told them of the potential harm of ect either.What was done to me should have never ever happened."somatron" might be the same.Fda safety report id# (b)(4).
 
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Brand Name
ELECTROCONVULSIVE TREATMENT MACHINE
Type of Device
DEVICE, ELECTROCONVULSIVE THERAPY
MDR Report Key8712478
MDR Text Key148733353
Report NumberMW5087460
Device Sequence Number1
Product Code GXC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Disability;
Patient Age56 YR
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