BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4240754 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17734
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 NON-SUSTAINED RV OVERSENSING EPISODES DUE TO RV LEAD NOISE WERE OBSERVED. PATIENT WAS ASYMPTOMATIC. THE OVERSENSING WAS UNABLE TO BE REPRODUCED IN-CLINIC. ALL MEASUREMENTS ON THE LEAD WERE NORMAL. PATIENT WILL RETURN FOR FOLLOW-UP. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723908 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR