BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955093 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00051
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    March 14, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. LATE DUE TO RE-EVALUATION OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD FEEL STIMULATION AROUND THE DEVICE WHEN RV PACING. IT WAS NOTED THAT THE LEAD IMPEDANCE HAS DROPPED. TECHNICAL SERVICES DISCUSSED THAT THERE MAY BE AN INSULATION BREACH. THE PHYSICIAN ELECTED TO REPROGRAM THE DEVICE. THE PATIENT HAS PULMONARY EDEMA, AND THE PHYSICIAN DOES NOT WANT THE PATIENT TO GO THROUGH ANOTHER OPERATION. THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR