BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 6033739 · Received October 17, 2016

    Report

    Report Number
    2938836-2016-12737
    Event Type
    Death
    Date Received
    October 17, 2016
    Date of Event
    June 22, 2015
    Report Date
    September 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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 CARDIAC ARRHYTHMIA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684707 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1258T/86 3610571

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death 1888TC/52, (B)(4)| 7120Q/65, (B)(4)| CD3231-40Q,820713