BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 9263271 · Received October 31, 2019

    Report

    Report Number
    3020533-2019-00003
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    May 1, 2018
    Report Date
    October 30, 2019
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    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 YEAR AFTER RECEIVING ELECTROCONVULSIVE THERAPY TREATMENTS FOR SEVERE DEPRESSION, A PATIENT IS BRINGING SUIT AGAINST MECTA (DEVICE MANUFACTURER) CLAIMING THAT THE TREATMENT CAUSED 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
    1053683 SPECTRUM SPECTRUM GXC MECTA CORPORATION 5000Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability