BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 9371285 · Received November 25, 2019

    Report

    Report Number
    3020533-2019-00005
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    May 1, 2018
    Report Date
    November 25, 2019
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAME LAW FIRM, (B)(6) IS REPRESENTING PLAINTIFFS IN REPORT #3020533-2019-00003 AND #3020533-2019-0004.

    Description of Event or Problem · 1

    APPROXIMATELY 1.5 YEARS AFTER RECEIVING ELECTROCONVULSIVE THERAPY TREATMENTS FOR DEPRESSION AND ANXIETY, A PATIENT IS BRINGING SUIT AGAINST MECTA (DEVICE MANUFACTURER) CLAIMING THAT THE TREATMENT CAUSED SRIOUS AND DEBILITATING COGNITIVE INJURIES. THE PATIENT ALSO CLAIMS MECTA DID NOT PROVIDE SUFFICIENT WARNING OF POTENTIAL HARMFUL CONSEQUENCES OF ECT TREATMENT IN GENERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166747 SPECTRUM SPECTRUM GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability