BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1003424 · Received February 22, 2008

    Report

    Report Number
    MW5005670
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 22, 2008
    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

    PATIENT HAD TEMPORARY PACEMAKER; THE WIRE BECAME DISLODGED FROM THE PACEMAKER NOT THE PT. POOR FIT. TAPE WAS APPLIED TO HELP THE DEVICE STAY IN. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SINGLE CHAMBER PACER DTE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other