BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3953226 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13606
    Event Type
    Death
    Date Received
    July 23, 2014
    Date of Event
    November 12, 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
    MS, 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

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COMPLAINTS OF EXERTIONAL DYSPNEA WITH CHRONIC ATRIAL FIBRILLATION AND CHF. THE PATIENTS CONDITION WORSENED AND THE PATIENT WAS TRANSFERRED TO THE ICU AND INTUBATED. LATER THAT EVENING, THE PATIENT WENT INTO PEA ARREST. EFFORTS TO RESUSCITATE THE PATIENT WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. 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
    431634 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death V-168, 334568