BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECT DEVICE

    MDR report key: 10376716 · Received August 6, 2020

    Report

    Report Number
    3020533-2020-00003
    Event Type
    Injury
    Date Received
    August 6, 2020
    Report Date
    August 6, 2020
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A LAW SUIT CURRENTLY BEING ADJUDICATED. IT INCLUDES SPECIFIC CLAIMS FOR THREE NAMED PLAINTIFFS.

    Description of Event or Problem · 1

    LAW SUIT CLAIMING NEUROCOGNITIVE INJURIES, MEMORY LOSS, IMPAIRED VISUAL AND VERBAL MEMORY, SIGNIFICANT DECLINE IN ABILITY TO LEARN AND RECALL INFORMATION, DISRUPTION AND DECLINE IN ABILITY TO ENCODE NEW INFORMATION, LOSS OF EXECUTIVE FUNCTION AND ADDITIONAL PHYSICAL AND PSYCHOLOGICAL HARMS.. PATIENT 1 ALLEGEDLY HAD 11 ECT TREATMENTS FOR DEPRESSION AND ANXIETY. PATIENT 2 ALLEGEDLY HAD 30 ECT TREATMENTS FOR DEPRESSION . PATIENT 3 ALLEGEDLY HAD 36 ECT TREATMENTS FOR DEPRESSION. AT THIS TIME, NO OTHER INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835830 ECT DEVICE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S