BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2571160 · Received May 7, 2012

    Report

    Report Number
    MW5025337
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    March 27, 2012
    Report Date
    May 7, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNABLE TO SCREW ATRIAL LEAD INTO PACEMAKER GENERATOR. DEVICE RETURNED TO ST. JUDE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL PACEMAKER DXY ST. JUDE MEDICAL 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability