BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3914604 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13128
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO AN ACUTE BLEED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389867 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death 1207-36, 493457