BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3220012 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04304
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 13, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    NEW INFORMATION INDICATED PACING LEAD IMPEDANCE INCREASED TO OUT OF RANGE WAS OBSERVED IN A FOLLOW UP. PACING CAPTURE THRESHOLD HAD INCREASED AS WELL. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED DURING FOLLOW UP, THE PACING LEAD IMPEDANCE CONTINUED TO INCREASE AND SENSING THRESHOLD REMAINED STABLE. X-RAY SHOWED THE LEAD APPEARED TO HAVE MOVED AND THE HELIX OF LEAD MAY HAVE RETRACTED. THE PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN INCREASE OF THE SENSING THRESHOLD AND LEAD IMPEDANCE WAS OBSERVED. PROVOCATIVE TESTING WAS PERFORMED AND NO NOISE OR CHANGES IN READINGS WAS NOTED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319777 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention