BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JUDE MEDICAL DEFIBRILLATION LEAD

    MDR report key: 2659038 · Received July 12, 2012

    Report

    Report Number
    MW5026175
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    December 29, 2011
    Report Date
    July 12, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ST. JUDE MEDICAL DEFIBRILLATION LEAD MODEL 1581. DEVICE WITH APPROPRIATE FUNCTIONING INCLUDING SENSING, THRESHOLD AND IMPEDANCE. DEFIBRILLATOR SHOCKING PORTION APPEARS TO BE NORMAL. FLUOROSCOPY DEMONSTRATES ABRASION OF THE INSULATION IN TWO DIFFERENT SPOTS NEAR THE RV COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL DEFIBRILLATION LEAD RIATA RV LEAD LWS ST. JUDE MEDICAL 1581 RG13749

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR