BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1881896 · Received October 19, 2010

    Report

    Report Number
    MW5017861
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING THE BATTERY COMPARTMENT FOR A BATTERY CHANGE, THE PACER TURNED OFF. ANOTHER PACER WAS AVAILABLE AT THE BEDSIDE AND WAS PLACED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DUAL CHAMBER TEMPORARY PULSE GENERATOR DTE MEDTRONIC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO