BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3943978 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13468
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 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
    MA, 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. AN ABORTED HIGH VOLTAGE CHARGE DUE TO POSSIBLE LEAD DAMAGE AND LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WERE NOTED. AN INSULATION BREAK AT THE SVC COIL WAS SUSPECTED, AND THE SVC COIL WAS PROGRAMMED OFF. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422478 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR