BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4133718 · Received October 1, 2014

    Report

    Report Number
    2938836-2014-16271
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 16, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED DEVICE CHANGE-OUT DUE TO NORMAL BATTERY DEPLETION, EXTERNALIZED CONDUCTORS WERE OBSERVED UNDER FLUOROSCOPY. THE LEAD REMAINS IMPLANTED. THE PATIENT WILL CONTINUE TO BE MONITORED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610894 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR