BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 6099920 · Received November 14, 2016

    Report

    Report Number
    2017865-2016-07156
    Event Type
    Death
    Date Received
    November 14, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751344 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1158T/75 2845046

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death