BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 4030767 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14727
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 DURING A FOLLOW UP, X-RAY SHOWED EXTERNALIZED CONDUCTORS. THE ELECTRICAL PARAMETERS WERE GOOD. THERE WERE NO ADVERSE CONSEQUENCES. THE LEAD REMAINS IMPLANTED AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510273 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1