BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3791329 · Received May 5, 2014

    Report

    Report Number
    2017865-2014-11983
    Event Type
    Death
    Date Received
    May 5, 2014
    Date of Event
    December 8, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267524 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4)