MAUDE Adverse Event Report: UNKNOWN ECT (ELECTROCONVULSIVE THERAPY) MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY

Device Problem Output Problem (3005)

Patient Problems Dyspnea (1816); Incontinence (1928); Inflammation (1932); Memory Loss/Impairment (1958); Nerve Damage (1979); Tinnitus (2103); Dizziness (2194); Anxiety (2328); Depression (2361); Shaking/Tremors (2515); Cognitive Changes (2551); Suicidal Ideation (4429); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2021

Event Type  Injury  

Event Description

I have been seriously injured as a direct result of undergoing nine ect treatments at (b)(6) behavioral health center in (b)(6) 2021.I was admitted there by my wife due to a breakdown as a result of excessive anxiety with some depression.I was diagnosed with treatment-resistant major depression with suicidal ideation.I was given the ect as the only intervention available to stabilize my condition.While the ect did bring me back to a baseline, it left me with the host of symptoms i described below: brain damage (tbi); damage to my autonomic nervous system; damage to my vagus nerve; cognitive impairment; short term memory loss; balance issues; hand tremors/loss of fine motor skills; cardiac issues; dizziness; trouble decision making; poor coordination; persistent buzzing noise in the left side of brain; unusual urinating patterns; impotence; teeth chattering; inconsistent breathing patterns; excessive sweating and other odd sensations.These symptoms are clearly physical or physiological in nature and not psychological, mood disorder-related or emotionally driven.I have done extensive research on my own about the dangerous side effects that can be caused by ect, which, by the way, is not regulated by the fda.According to reliable sources, i need to undergo a functional mri to detect the damage done.Further, i need to see a clinician familiar with repetitive concussions, closely spaced violent seizures, vagus nerve damage, electrical injury, blood-brain barrier, non ionizing injury, electrolyte processing, brain inflammation, neuronal loss, trigeminocardiac nerve, demyelination, cns dysfunction and optometric rehabilitation.Fda safety report id # (b)(4).

• Brand Name: UNKNOWN ECT (ELECTROCONVULSIVE THERAPY) MACHINE
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 14621425
• MDR Text Key: 293472596
• Report Number: MW5110129
• Device Sequence Number: 1
• Product Code: QGH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• 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 Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White