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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELECTROCONVULSIVE THERAPY MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY
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ELECTROCONVULSIVE THERAPY MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Memory Loss/Impairment (1958); Therapeutic Response, Decreased (2271); Cognitive Changes (2551)
Event Date 09/01/2010
Event Type  Injury  
Event Description
I was administered 6 courses of electroconvulsive therapy (ect) at (b)(6) center in (b)(6) over a two week period in (b)(6) 2010 by dr barry kramer.The ect resulted in severe short and long-term memory loss, as well as personality changes and worsening mental health.I was being treated for manic episodes of bipolar disorder, which i later learned was an illness that i did not have.I was misdiagnosed and given several psychotropic medications that resulted in behavioral toxicity that made it appear i had worsening bipolar symptoms.I was prescribed ect treatment with no informed consent.The effects were dangerous and long-lasting.Almost ten years later, i still have permanent memory loss from that time.The effects on my behavior were also severely detrimental, costing me my marriage, my home, and my job.Fda safety report id# (b)(4).
 
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Brand Name
ELECTROCONVULSIVE THERAPY MACHINE
Type of Device
DEVICE, ELECTROCONVULSIVE THERAPY
MDR Report Key9915820
MDR Text Key186379549
Report NumberMW5094023
Device Sequence Number1
Product Code GXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
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 Number1
Patient Outcome(s) Disability;
Patient Age51 YR
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