BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 4220680 · Received November 3, 2014

    Report

    Report Number
    2017865-2014-17675
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    July 15, 2014
    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 Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701167 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death 3231, (B)(4), 1688, (B)(4), 7122, (B)(4)