BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3781836 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10108
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    December 8, 2013
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN THREE SEGMENTS FOR ANALYSIS. THE PORTIONS OF THE LEAD THAT WERE RETURNED WERE OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED BUT THE CAUSE WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259176 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4), (B)(4)