BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 12363595 · Received August 24, 2021

    Report

    Report Number
    3020533-2021-00007
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    July 31, 2018
    Report Date
    August 24, 2021
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 BRAIN DAMAGE AND PERMANENT MEMORY LOSS, BRAIN INJURY, AND NEUROCOGNITIVE INJURY; DEVELOPED PERMANENT MEMORY LOSS AND COGNITIVE IMPAIRMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259694 SPECTRUM SPECTRUM GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability