BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781908 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09898
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 26, 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
    NJ, 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 RECEIVED AN ALERT FOR HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE. TREND REVIEW SHOWED OUT OF RANGE MEASUREMENTS. THESE MEASUREMENTS WERE NOT REPRODUCED IN CLINIC. THE PATIENT AND LEAD WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259037 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR