BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3781786 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10067
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    February 6, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ASSOCIATED DEVICES CONTINUED - (B)(4); (B)(4);.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO AN UNKNOWN CARDIAC RELATED ISSUE. 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
    259803 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death (B)(4), (B)(4), (B)(4),