BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1955186 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00359
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NOISE WAS OBSERVED ON THE LEAD. R-WAVES AND THE PACING LEAD IMPEDANCE SHOWED A DECREASE SINCE IMPLANT AND THE CAPTURE THRESHOLD HAD INCREASED. THE SENSITIVITY WAS RESOLVED WITH PROGRAMMING. THE LEAD WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR