BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT / ST.JUDE MEDICAL

    MDR report key: 13059758 · Received December 20, 2021

    Report

    Report Number
    MW5106189
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    December 10, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ABBOTT JUSTIFIED OTHER SECTION THAT REMOTE MONITORING INDICATES SUGGEST ABNORMAL BATTERY BEHAVIOR IN THIS PACEMAKER, ON ADVISORY. PT IS PACEMAKER DEPENDENT. HE PRESENTED FOR GENERATOR CHANGE. THE DEVICE WAS FOUND IC, AN ABNORMAL MAGNET MADE WITH VVI PACING AT 90 BPM. TECH SERVICES WERE CALLED, AND MAGNET MODE WAS TURNED OFF WHICH RESULTED IN CHANGE BACK TO DDD MODE AND NORMAL PACING BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939219 ABBOTT / ST.JUDE MEDICAL PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ ABBOTT MEDICAL PM2240

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention