BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4173936 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16703
    Event Type
    Malfunction
    Date Received
    October 15, 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
    CA
    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 WHEN THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, X-RAY REVEALED EXTERNALIZED CONDUCTORS. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. LEAD REMAINS IMPLANTED. PATIENT WILL BE MONITORED VIA ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654109 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1590/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1