BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROCONVULSIVE THERAPY

    MDR report key: 1577536 · Received January 7, 2010

    Report

    Report Number
    MW5014282
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    September 23, 2007
    Report Date
    January 7, 2010
    Product Code
    GXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM NOT ACTUALLY SURE WHEN THE STARTING DATE OF MY SECOND ROUND OF ECT STARTED. I HAVE NO PAPERWORK, NO CONSENT FORM, MY FAMILY DIDN'T KNOW HOW THE PROCEDURES WERE AFFECTING ME, AND MY DOCTOR WAS EXTREMELY RELUCTANT TO GIVE ME ANY INFO ABOUT THE PROCEDURES AFTERWARD. I HAD ASKED TO MAKE ANOTHER APPOINTMENT WITH HIM ABOUT A YEAR AFTER THE PROCEDURES WERE OVER. HE REFUSED. I FOUND OUT ABOUT A YEAR AGO THAT I HAD A PREVIOUS SESSION OF ECT IN 2006, WHICH WAS CUT SHORT, DUE TO THE FACT THAT MY INSURANCE COMPANY CHANGED AFTER 6 SESSIONS. I HAVE NO IDEA WHO MY CARETAKER WAS DURING THAT PERIOD. IT IS THE ECT THAT WAS STARTED IN 2007, THAT CONCERNS ME. MY DOCTOR DID NOT INFORM ANYONE OF THE POSSIBILITY OF THE SEVERITY OF THE MEMORY LOSS OR THE LOSS OF COGNITIVE ABILITY I COULD HAVE. I ENDED UP NOT REMEMBERING ALMOST NOTHING OF THE LAST HALF OF 2007. ONE THING THAT STUCK, THOUGH, WAS THAT MY DOCTOR ASKED ME FOR CONSENT TO ADD ADDITIONAL ECT PROCEDURES WHILE I WAS BEING TREATED. WHEN I STARTED TREATMENT, A FRIEND OF MINE, TOOK ME TO APPOINTMENTS. AFTER SHE TOOK ME HOME, APPARENTLY I WAS DRIVING. MY HEADLIGHTS AND TAIL LIGHTS HAD BEEN BROKEN OUT. WHEN I STARTED GETTING MY MEMORY BACK, MY FAMILY IS UNSURE OF HOW TO DEAL WITH ME. I DONT' KNOW HOW TO DEAL WITH MYSELF. MY PERSONALITY HAS TOTALLY CHANGED. I CANNOT STOP TALKING. I USED TO BE EXTREMELY QUIET AND SHY. MY EMOTIONAL REACTIONS ARE VERY DIFFERENT. I AM STUDYING BOOKS IN ORDER TO FIT IN WITH SOCIETY. I STILL HAVE MEMORY LOSS; I CARRY A NOTEBOOK AROUND WITH ME WHEREVER I GO TO RECORD APPOINTMENTS. I DON'T REMEMBER PEOPLE'S NAMES THAT I HAVE KNOWN FOR MONTHS. I DON'T KNOW HOW TO DEAL WITH THIS NEW ME. I HAVE ALIENATED MY FAMILY. I HAVE NO FRIENDS. NONE OF MY DOCTORS WILL ADDRESS THIS SUBJECT. NONE OF THEM KNEW ME PRIOR TO THE ECT. I USED TO BE VERY INTELLIGENT. MY COLLEGE ENTRANCE EXAMS WOULD HAVE ALLOWED ME TO GO TO ANY COLLEGE I WANTED. I WAS IN THE 99TH PERCENTILE. NOW I CANNOT REMEMBER WORDS. I WRITE IN GIBBERISH. I HAVE TO WAIT UNTIL THE NEXT DAY, AND REWRITE LETTERS. I DON'T EVEN KNOW WHAT I WAS TRYING TO SAY. I CAN ONLY PARK MY CAR TO THE LEFT. MY SPATIAL RECOGNITION WORKS ONLY PARTIALLY. THIS PROCEDURE NEEDS TO BE RESEARCHED BEFORE ITS USE IS CONTINUED, AND SOME VERY SPECIFIC GUIDELINES NEED TO BE IN PLACE IF ITS USE IS TO BE CONTINUED. DATES OF USE: 2006 - 2007. DIAGNOSIS OR REASON FOR USE: DEPRESSION, DEPRESSION/SUICIDAL. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROCONVULSIVE THERAPY ELECTROCONVULSIVE THERAPY GXC 2009-N-0392

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening| O| R