BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901333 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12678
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 2, 2012
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE OBSERVED VIA X-RAY. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379941 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1591/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR