BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 10733345 · Received October 26, 2020

    Report

    Report Number
    10733345
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    May 24, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MEDTRONIC
    Product Code
    OVJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER STOPPED WORKING WHEN BATTERY CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201797 MEDTRONIC DUAL CHAMBER PACEMAKER OVJ MEDTRONIC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA