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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN ECT DEVICE; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND

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UNKNOWN ECT DEVICE; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Fatigue (1849); Headache (1880); Low Blood Pressure/ Hypotension (1914); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Neuropathy (1983); Tinnitus (2103); Dizziness (2194); Arthralgia (2355); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Cognitive Changes (2551); Balance Problems (4401); Suicidal Ideation (4429); Increased Sensitivity (4538)
Event Date 07/16/2001
Event Type  Injury  
Event Description
I had eight bilateral ect treatments between (b)(6) 2001, at (b)(6) hospital in (b)(6), for "treatment-resistant depression." i initially consented, but i decided to stop treatment after i began.The doctors coerced me into "compliance" by threatening to get a court order to force treatment.The doctors denied me access to an attorney and refused to give me a phonebook to call one.I became increasingly distressed as treatment progressed and my symptoms worsened.Despite this, they continued ect against my expressed wishes.I attempted suicide a few days after treatment ended.I was a professional photographer before ect.Afterward, i could not remember how to use my camera or basic photographic concepts.Several months of my life were erased by the ect, including many precious memories and life events.I had great difficulty carrying on a conversation because i would forget the words i was saying before finishing a sentence.I continually asked, "did i just say that? did i already talk about that?" the response was often, "yes, you already talked about that" or "i don't know what you are trying to say." i had to carry around a notebook to write the names of people i met, where i met them and a description of their appearance.I bought devices (pda) to help me remember events and appointments.I started putting post-it notes all over my house to help me remember daily tasks.I documented these symptoms and ongoing distress about them in my journal for several years after ect.I developed excruciating headaches, neck and back pain, jaw pain, tmj, teeth-grinding, and tinnitus immediately after ect.I struggle with learning/retaining new material, reading, writing, spelling, following instructions, memorization, word-finding, working memory, attention, focus, multitasking, planning, organization, task completion, recall of information, and auditory/visual/ cognitive processing.I did not have the problems before ect.Everyday functioning takes an enormous amount of time, energy, and effort and causes me to feel exhausted/overwhelmed.Since ect, i have not been able to work full-time and sometimes not at all.I also require work/school accommodations.My psychiatrist repeatedly denied that my symptoms were related to the ect.He blamed them on "depression," even though they were not present beforehand.He never referred me for evaluation or treatment.He kept prescribing more drugs at higher doses and new classes of psych drugs i was not taking before ect.Despite this, my psychiatric problems continued to worsen.Now i am developing nervous system/neurological problems found in people with other brain or electrical injuries, including cognitive impairment, meniere's disease, dry eye disease, non-diabetic neuropathy, numbness, tingling, dizziness, balance/coordination problems, dysautonomia, post-traumatic headaches, nausea, sleep disorder, fatigue, weakness, muscle fasciculations, temperature regulation issues, joint and neuromuscular pain/stiffness, post-exertional malaise, brain fog, sensitivity to light/sound, sensory overload, visual disturbances, postural orthostatic hypotension, palpitations and arrhythmias.Please note: i am in my mid-forties, a healthy weight, and i do not drink alcohol, smoke, or use drugs.I was recently diagnosed with acquired brain injury w/ post-concussion symptoms from the ect by a clinical neuroscientist.(y.84.3 shock therapy as cause of abnormal reaction of patient, or of later complication without mention of misadventure at time of procedure).Ect caused severe, life-long physical, psychological, and emotional suffering and ongoing financial hardships due to extensive medical costs to treat/manage my symptoms and its impact on my ability to work and function.I continue to have flashbacks and nightmares about my treatment and live in constant fear that it will be forced on me again, and even worse-on my children.It took over 2 decades to receive an appropriate diagnosis of the brain/neurological injury i sustained from ect.The hospital did not inform my husband or me of these risks.I would never have elected to have it if we had known the risks described in the ect device user manuals, the apa's ect taskforce report (1990; 2001), and 83 years of scientific literature.The doctors at (b)(6) hospital did not follow appropriate informed consent procedures-very common in the us.Ect patients are told not to make important life decisions or sign contracts during a course of ect and for a period of time following it, as they are in an altered state of consciousness.As such, any consent given by the patient after the first ect session is not valid per contract and consent laws.Likewise, since patients often give "consent" while experiencing undue influence from doctors and family, duress, coercion, and threats of involuntary ect and hospitalization, it is not valid per contract and consent laws."labeling" for the identified risks of ect provides no protection for non-consenting patients.Labeling simply warns us that ect is harmful and should not be used; it does not change the damaging effect of electrical current and seizures on the brain/body.The fda and medical community continue to deny the damage caused by running electricity through the brain to induce seizures, despite acknowledging the detrimental effects of seizure disorders and electrical injuries on the brain/body.Fda claims to incorporate real world data and real wold evidence into their decisions, yet dismisses 83 years of patient/practitioner experience of damage/suffering as non-scientific and non-valid.The fda, us government, and apa have never responded to the suffering and pleas of people whose lives have been destroyed by ect.They have ignored, dismissed, and lied to us since 1941.The apa and the medical community have failed in their duty to "do no harm" and the fda and government have failed in their duty to protect americans.Fda safety report id # (b)(4).
 
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Brand Name
ECT DEVICE
Type of Device
ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND
Manufacturer (Section D)
UNKNOWN
unknown
unknown
MDR Report Key14511724
MDR Text Key292715475
Report NumberMW5109908
Device Sequence Number1
Product Code QGH
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 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention; Life Threatening;
Patient Age46 YR
Patient SexFemale
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