MAUDE Adverse Event Report: MECTA CORPORATION ELECTROCONVULSIVE THERAPY MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Memory Loss/Impairment (1958); Respiratory Distress (2045); Viral Infection (2248); Fungal Infection (2419)

Event Date 11/17/2018

Event Type  Injury  

Event Description

Since approx more than 80 maintenance bilateral ect, in addition to pervasive autobiographical memory loss, working memory deficits and impaired cognitive processing speed, i now have a new development.Any time i get my bacterial, viral or fungal infection, it goes directly to my brain triggering painful dystonia.Airborne pathogens go directly to my brain at times triggering painful dystonia, dyskinesia-type erratic movements, parkinsonism-type gait and most recently diaphragmatic paralysis.I believe this is a direct result of ect's hypertensive surge bursting lesions causing blood-brain-barrier hyper permeability.Cognitive and neuromuscular function is directly related to whatever pathogens are in the air and/or blood borne biotoxins (including digestive byproducts).I was hospitalized overnight in the fall of 2017.I've had multiple visits to the er.The problem has progressed to the point that i experience diaphragmatic paralysis 3-10 or more times a month (if i choose to go into buildings which aren't hepa filtered).Instead, i am basically confined to my home and hepa air-filtration, forced to quit working due to the inconsistency of my neurological, neuromuscular and respiratory problems.Dystonia, and respiratory problems completely ameliorate when i am pathogen-free.The date listed is merely the most recent incident.Uncertain which model.

• Brand Name: ELECTROCONVULSIVE THERAPY MACHINE
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): MECTA CORPORATION
• MDR Report Key: 8095060
• MDR Text Key: 128265665
• Report Number: MW5081540
• Device Sequence Number: 0
• Product Code: GXC
• 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: 11/19/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 66