BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST PASSIVE FIXATION

    MDR report key: 4173915 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16695
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 DURING A DEVICE CHANGE-OUT, EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD REMAINS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654045 RIATA ST PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7040/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1