BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTA SPECTRUM

    MDR report key: 14349811 · Received May 10, 2022

    Report

    Report Number
    3020533-2022-00002
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    December 31, 2021
    Report Date
    May 10, 2022
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FROM A MEDWATCH REPORT FILED BY A PHYSICIAN WHO GAVE NO CONTACT INFORMATION. HENCE, IT WAS NOT POSSIBLE TO FOLLOW UP IN ANY WAY. HOWEVER, MECTA HAS OBTAINED THE PAPER AND REVIEWED THE FINDINGS. AS NOTED EARLIER, NO DIRECT DEMONSTRATION OF AN UNTOWARD EFFECT OF ECT ON ANY BIOLOGICAL OR FUNCTIONAL DOMAIN.

    Description of Event or Problem · 0

    JOURNAL ARTICLE SUGGESTING HEIGHTENED LEVELS OF OXIDATIVE DNA DAMAGE MARKER 8-HYDROXY-20-DEOXYGUANOSINE (8-OHDG). INTERNATIONAL JOURNAL OF PSYCHIATRY IN CLINICAL PRACTICE, EFFECTS OF ELECTROCONVULSIVE THERAPY ON NITROSATIVE STRESS AND OXIDATIVE DNA DAMAGE PARAMETERS IN PATIENTS WITH A DEPRESSIVE EPISODE; PUBLISHED ONLINE: 24 JAN 2022. THIS ARTICLE DESCRIBES NO DIRECT DEMONSTRATION OF AN UNTOWARD EFFECT OF ECT ON ANY BIOLOGICAL OR FUNCTIONAL DOMAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100575 MECTA SPECTRUM ECT DEVICE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other