BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

    MDR report key: 11308860 · Received February 10, 2021

    Report

    Report Number
    11308860
    Event Type
    Death
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 28, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    TRANSVENOUS PACEMAKER FIRED R ON T WAVE. PATIENT WENT IN VFIB ARREST. ACLS PROTOCOL INITIATED AND FOLLOWED. UNABLE TO REGAIN AND MAINTAIN RETURN OF SPONTANEOUS CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207994 MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246 PULSE GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC, INC. 5392 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death