BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX LV LEAD

    MDR report key: 6144518 · Received December 5, 2016

    Report

    Report Number
    2938836-2016-14824
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    July 30, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796900 QUICKFLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1156T/86 0002129560

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 1888TC/46, BCJ11377| 7121/65, AHD15158| CD3231-40, 627853