BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992811 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09655
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE A RA (RIGHT ATRIAL) LEAD WAS PLACED AND THE POCKET WAS CLOSED. THE POCKET WAS THEN OPENED TO CHECK THE LEAD CONNECTIONS AND RECLOSED. IT WAS THEN FOUND THAT THE ATRIAL LEAD HAD DISLODGED, SO THE POCKET WAS RE-OPENED AGAIN AND THE ATRIAL LEAD WAS REMOVED. A NEW REPLACEMENT LEAD WAS THEN ATTEMPTED TO BE IMPLANTED BUT ALSO DISLODGED. THE PHYSICIAN THEN DECIDED TO REMOVE THE REPLACEMENT LEAD AND RE-IMPLANT THE INITIAL ATRIAL LEAD. THE RE-IMPLANTING OF THE INITIAL ATRIAL LEAD WAS SUCCESSFUL AND REMAINS IN USE. IT WAS NOTED THAT THE POST-DAY CHECK SHOWED THAT THE ATRIAL LEAD WAS FUNCTIONAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469243 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR