BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2941469 · Received January 28, 2013

    Report

    Report Number
    MW5028811
    Event Type
    Death
    Date Received
    January 28, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PERICARDIAL COMPONADE DUE TO HEMOPERICARDIUM. IT WAS SUSPECTED THAT THIS WAS CAUSED BY A PERFORATION OF THE RIGHT VENTRICLE WALL DURING IMPLANTATION OF NEW DEFIBRILLATOR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38113 ST. JUDE MEDICAL MEDTRONIC SINGLE COIL DEFIBRILLATOR LEAD LWS ST. JUDE MEDICAL 6935M/55 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death