BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860031 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05620
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 TWO ATRIAL LEADS WERE ATTEMPTED BUT NOT USED DURING IMPLANT PROCEDURE. THE FIRST ATRIAL LEAD EXHIBITED PLACEMENT DIFFICULTIES AND THE HELIX WOULD NOT FIXATE TO THE ATRIAL WALL. THE SECOND LEAD HELIX BECAME STUCK IN THE EXTENDED POSITION WHILE ATTEMPTING TO PLACE LEAD. ADDITIONALLY, IT WAS NOTED THAT THE STYLETS WERE DIFFICULT TO INSERT AS THERE WAS BLOOD ON THE STYLETS AND INSIDE THE LEAD. DIFFICULT PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THE INABILITY TO PLACE THE LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340234 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR