BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 876276 · Received July 3, 2007

    Report

    Report Number
    MW5002939
    Event Type
    Malfunction
    Date Received
    July 3, 2007
    Date of Event
    June 8, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE SCREW WOULD NOT INSERT ON THE ATRIAL HEADER OF THE PACEMAKER. AFTER MULTIPLE ATTEMPTS, A DIFFERENT PACEMAKER WAS UTILIZED WITH NO PROBLEMS. DIAGNOSIS: NEEDED FOR DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACEMAKER-VICTORY XL DR PULSE GENERATOR DXY ST JUDE MEDICAL 5816

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other