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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECT MACHINE; ELECTROCONVULSIVE THERAPY

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ECT MACHINE; ELECTROCONVULSIVE THERAPY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Memory Loss/Impairment (1958); Cognitive Changes (2551)
Event Type  Injury  
Event Description
Extreme loss of memory, cognitive function, emotions and personality change began after 1st ect treatment in (b)(6) 2015.By 3rd or 4th treatment, doctor walks in operating room as i am being hooked up and anesthesia being started, and gleefully says well, (b)(6) so how do you think you're doing? much better!! i hesitated, said no, not really.Not yet (trying to be "complaint" as per my personality), i told him, but mentioned i'd seen while (b)(6) on my phone there were 2 different kinds of ect, with oral possibly working better."bilateral?" i asked doctor said "oh, yes, well ok, yeah! we can try that", ok, so all i did was mention a term, for his explanation/clarification and any advise he had rather whether it may work better on my type depression.At no point before, or during the procedure was the true effectiveness stated to me, which is approx 52% for my mental illness-diagnosed with clinical depression over 25 yrs ago after meningitis with approx 20 yrs of medication resistance, including his monthly or b-monthly pt of over 5 yrs straight.He had tried me on over 10 different combinations of and depression and psychotic meds, all of little to no help or worse.Suicidal state for yrs and he had been strongly suggesting the ect for months with only glowing remarks about it's highly effective treatment of major depression stating (during a visit/consult with my mom, dad, rn sister and other sister, who is married to an internist pyd) a cure rate of over 80%.I vaguely remember he may have mentioned some confusion and loss of memory i may experience the day of treatment.Had been admitted to inpatient hospital psyche ward previous day to 1st ect treatment.I was awoke after 10:30 pm that night after nurse giving me my nightly meds including sleeping pill) when he stepped in my dark room, woke me up and asked could i come with him.We needed to go over stuff (i'm assuming that was my signing of the consent in order to begin treatment the next am.All i remember is sitting across from my dr at a small round table while he flipped through a huge binder taking while all i could do was repeat over and over in my head "why am i in here? wasn't i just asleep? try to ack like you're listening." so i was working hard to pretending to listen while he had to know i was out of my mind.Found a job (b)(6) 2016 which lasted 2 wks.Recd (b)(6) scholarship in (b)(6) and passed medical billing and conding fast track at local community college (b)(6) 2016 with an "a" avg, then failed (36%) (b)(6) cert test (b)(6) 2016.Working with long time friend who hired me pt (b)(6) 2016 after a week she kept saying "(b)(6), i told you, whatever it was" so i finally had to tell her i'd had ect and lost memory and ability to comprehend/remember things.She had not seen me in 10 yrs and the look in her eyes told me everything i proceeded to write down my schedule wrong several times and had to be called in.It's retail, and i have to ask customer's name to write on their dressing room door and half the time after standing by closed door a bit, finally have to embarrassingly ask "ma'am, what did you say your name was?" ect has devastated me.As if suicide and depression that never lifted in yrs, now i can't do the one thing i've excelled in since i could write.I'm constantly misspelling words or locking up spelling if i'm able and transposing numbers and even my own name! you can't imaging the feeling if i notice my signing stuff at work or a card or something, and misspelled my own name.Ect disclosures do not back up specific evidence and research is mostly irrelevant since i find out regs being used over 20-30 yrs outdated and bad to no clinical f/u, after 6 months from my findings.And ect still being used by a "temporary" fda approval? surely this is incorrect.
 
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Brand Name
ECT MACHINE
Type of Device
ELECTROCONVULSIVE THERAPY
MDR Report Key6215334
MDR Text Key63723425
Report NumberMW5066992
Device Sequence Number1
Product Code GXC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Treatment
1 40MG/DAY TO REDUCE COSTS; ABILIFY,; ADDERALL 30MG 2/DAY; BACLOFEN,; CALCIUM; DR PRESCRIBED THE FOLLOWING WHICH I CAN'T AFFORD: ; FETZIMA,; FIORICET ,; LIPITOR,; MULTI-VITAMIN; PROZAC PRESCRIBED AT 40MG X 2/DAY, I ONLY TAKE; TOPOMAX,; VITAMIN D; XANAX 1MG AS NEEDED AT NIGHT; YEARLY SHOT PROLIA (ALMOST 2 YRS OVERDUE).
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age54 YR
Patient Weight79
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