BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161102 · Received October 10, 2014

    Report

    Report Number
    3008973940-2014-00385
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT AND THE LEAD INDICATED STRETCHING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD HAD TO BE REPOSITIONED THE LEAD A FEW TIMES, DUE TO POOR SENSING. THE LAST TIME THE SCREW DID NOT COME OUT SMOOTHLY BUT JUMPED OUT SUDDENLY. IT WAS ALSO NOTED THE SENSING HAD DROPPED. THE LEAD WAS ATTEMPTED AND NOT USED. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637443 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1