BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 12154550 · Received July 12, 2021

    Report

    Report Number
    3020533-2021-00006
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 11, 2018
    Report Date
    July 12, 2021
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 3 YEARS AFTER RECEIVING A SERIES OF ELECTROCONVULSIVE THERAPY TREATMENTS, PATIENT CLAIMS THE FOLLOWING: NOT WARNED OF RISKS OF PERMANENT MEMORY LOSS, BRAIN INJURY, AND NEUROCOGNITIVE INJURY; DEVELOPED PERMANENT MEMORY AND COGNITIVE IMPAIRMENTS AS WELL AS DELAYED REACTIONS, RATHER THAN IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052731 SPECTRUM SPECTRUM GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability