BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2973393 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00169
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 28, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION STATES THAT RE-EVALUATION OF LEAD IMAGE SHOWED NORMAL RESULTS. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76598 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR