BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROCONVULSIVE DEVICE

    MDR report key: 14395405 · Received May 13, 2022

    Report

    Report Number
    MW5109663
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    May 19, 2021
    Report Date
    May 11, 2022
    Manufacturer
    UNK
    Product Code
    QGH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS BAKER ACTED ON (B)(6) 2021 TO A PSYCHIATRIC FACILITY IN (B)(6) FOR PLANNING MY SUICIDE. THE NEXT DAY DOCTORS CAME TO MY ROOM AND TALKED TO ME ABOUT ECT, I SIGNED CONSENT. I HAVE LITTLE MEMORY OF MY NEXT 10 DAYS THERE. I HAD 3 ECT TREATMENTS IN THE HOSPITAL AND CONTINUED AS AN OUTPATIENT FOR THE NEXT 2 MONTHS. I HAVE NO MEMORIES UNTIL (B)(6) 2021. I WAS HAVING OXYGEN ISSUES AND CHEST PAINS, AFTER STABILIZING, WE PROCEEDED. I HAD A VERY BAD HEADACHE AFTERWARDS AND FELT REALLY BAD, BAD ENOUGH THAT WE WENT TO THE ER FOR HELP. I RECEIVED MEDICATION AND TESTS. THAT WAS MY LAST OF 13 TREATMENTS. MY MEMORY HAS BEEN GREATLY AFFECTED, BUT HAS ALSO IMPROVED WITH A NEW TREATMENT OF SPRAVATO. A YEAR LATER, I AM STILL STRUGGLING. I AM ON DISABILITY NOW AND HAVE RETIRED FROM TEACHING AFTER 31 YEARS. MY FAMILY CAN VOUCH FOR MY MEMORY ISSUES, AND I WAS A PERSON WHO USED TO JUGGLE A MILLION THINGS AND HAD A NEAR PERFECT MEMORY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112453 ELECTROCONVULSIVE DEVICE DEVICE, ELECTROCONVULSIVE THERAPY QGH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Disability| R