BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX LV LEAD

    MDR report key: 6122165 · Received November 22, 2016

    Report

    Report Number
    2017865-2016-07295
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 29, 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 DECEASED DUE TO CONGESTIVE HEART FAILURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770662 QUICKFLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1156T/86 2792242

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death (B)()