BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 2250242 · Received September 15, 2011

    Report

    Report Number
    2017865-2011-06662
    Event Type
    Death
    Date Received
    September 15, 2011
    Date of Event
    December 3, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 EXPIRED. NO KNOWN CAUSE WAS REPORTED OR DEVICE ISSUES. ADDITIONAL INFORMATION COULD NOT BE OBTAINED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death GUIDANT H217, (B)(4), MEDTRONIC 4194, (B)(4)