BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3260255 · Received August 1, 2013

    Report

    Report Number
    2017865-2013-05039
    Event Type
    Death
    Date Received
    August 1, 2013
    Date of Event
    June 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATIONS FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360879 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death (B)(4), (B)(4), (B)(4)