BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3914621 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13162
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUOROSCOPY SHOWED EXTERNALIZED CONDUCTORS. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390915 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR