BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 3914401 · Received July 3, 2014

    Report

    Report Number
    2017865-2014-13997
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    May 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED STATED THAT THE PATIENTS FOLLOWING PHYSICIAN WAS NOT AWARE THAT THE PATIENT HAD DECEASED. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390750 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1258T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death (B)(4)