BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACER BOX

    MDR report key: 19258524 · Received May 7, 2024

    Report

    Report Number
    19258524
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 17, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SURGEON PLACED ATRIAL AND VENTRICULAR PACING WIRES, MEDTRONIC PACER BOX WAS UNABLE TO PICK UP PATIENT HEART RHYTHM. SURGEON PLACED NEW WIRES AND CABLE, BUT DID NOT FIX THE PROBLEM. NEW PACER BOX WAS THEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530851 PACER BOX PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC, INC. DJH034586P

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female