BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3854725 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11560
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 16, 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 DURING FOLLOW-UP, A VARIATION IN HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. FOR A FEW MONTHS, THE HIGH VOLTAGE LEAD IMPEDANCE WAS HIGH, OUT OF RANGE, BUT THEN RETURNED TO STABLE IN-RANGE VALUES. THE LEAD WAS TESTED IN CLINIC AND THE HIGH VOLTAGE LEAD IMPEDANCE WAS IN-RANGE AND STABLE. LEAD REMAINS IMPLANTED. PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331100 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR