BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3781793 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10106
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    February 12, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    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 CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259891 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death (B)(4), (B)(4), (B)(4)