BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT RV LEAD 0145

    MDR report key: 2748613 · Received September 11, 2012

    Report

    Report Number
    2748613
    Event Type
    Other
    Date Received
    September 11, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST. JUDE MED, INC
    Product Code
    DTB
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO TAKE OUT A PACEMAKER LEAD, THE LEAD BROKE AND THE PT NEEDED EMERGENT THORACOTOMY FOR RETRIEVAL OF A BLEED FRAGMENT FROM RIGHT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT RV LEAD 0145 PACEMAKER LEAD DTB ST. JUDE MED, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR