BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3953295 · Received July 23, 2014

    Report

    Report Number
    2938836-2014-13589
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL KINK IN THE INNER COIL ON THE MID PORTION OF THE LEAD WAS NOTICED VIA FLUOROSCOPY. LEAD REMAINS IMPLANTED, AS NORMAL ELECTRICAL FUNCTIONALITY WAS OBSERVED. THE PATIENT WAS WELL AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431617 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1590/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR