BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902603 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00293
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 16, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, AND MANDATORY MEDWATCH FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW UP, NOISE AND NO CAPTURE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8555 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR