BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3944033 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13380
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 10, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO NORMAL ERI AN INSULATION ANOMALY WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD EXHIBITED NO ELECTRICAL ANOMALIES AND THE PATIENT WAS ASYMPTOMATIC. THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL CONTINUE WITH ROUTINE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422171 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR