FDA Adverse Event Injury Summary report: N

UNKNOWN ECT (ELECTROCONVULSIVE THERAPY) MACHINE

MDR report key: 14621425 · Received June 7, 2022

Report

Report Number
MW5110129
Event Type
Injury
Date Received
June 7, 2022
Date of Event
March 1, 2021
Report Date
June 3, 2022
Manufacturer
UNK
Product Code
QGH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
646609 UNKNOWN ECT (ELECTROCONVULSIVE THERAPY) MACHINE DEVICE, ELECTROCONVULSIVE THERAPY QGH UNK

Patients

Seq Age Sex Outcome Treatment
1 59 YR Male Disability