BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3914591 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13149
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 22, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH, OUT OF RANGE PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS WERE OBSERVED ON THE RV LEAD. FLUOROSCOPY WAS PERFORMED AND LEAD WAS STRUCTURALLY FINE. IT WAS REPORTED THAT THE PATIENT DOES NOT REQUIRE PACING. THE PATIENT ALERT LIMIT WAS INCREASED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390468 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR