BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3943992 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13438
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 30, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF THE IMPLANT PROCEDURE, HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE POSITION OF THE LEAD WAS GOOD AND THE LEAD REMAINS IMPLANTED. THE HIGH VOLTAGE LEAD IMPEDANCE ALERT WAS PROGRAMMED OFF AND THE IMPEDANCE WILL BE ASSESSED AT THE NEXT PATIENT FOLLOW-UP. THE PATIENT CONDITION WAS GOOD BEFORE AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422918 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1