BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 4159045 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02584
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN POSITIONED THE LEAD BUT THE FIXATION WAS NOT STABLE ON THE CARDIAC MUSCLE AS IT J CURVED LEAD. THE LEAD WAS ATTEMPTED AND NOT USED. THE REPLACEMENT LEAD WAS APPROACHED FROM RIGHT CHEST DUE TO PATIENT CLINICAL CONDITION AND THE PATIENT HAD THORACOTOMY PROCEDURE BEFORE SO THE LEAD BECAME SLIGHTLY HARDER. THE PROCEDURE TOOK FAR TOO LONG BECAUSE OF ABOVE STATEMENT THEN CONTROL OF THE STYLET BECAME "UNSMOOTH MOVEMENT" AND FIXING OF THE HELIX WAS NOT GREAT. 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
    641405 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR