BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 6099749 · Received November 14, 2016

    Report

    Report Number
    2938836-2016-14158
    Event Type
    Death
    Date Received
    November 14, 2016
    Date of Event
    May 12, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED AT HOME. THE PATIENT HAD ANTECEDENT WORSENING HEART FAILURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750282 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1258T/86 3649429

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 1999/52, (B)(4)| 7121Q/58, (B)(4)| CD3231-40Q, 810695