BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3470032 · Received November 14, 2013

    Report

    Report Number
    2182208-2013-03157
    Event Type
    Death
    Date Received
    November 14, 2013
    Date of Event
    September 4, 2009
    Report Date
    February 1, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. WITHOUT THE LEAD SERIAL NUMBER THE MANUFACTURING DATE CANNOT BE DETERMINED. CONCOMITANT MEDICAL PRODUCTS: IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR, PRODUCT ID C174AWK, IMPLANTED: (B)(6) 2009; IMPLANTABLE DEFIBRILLATION LEAD, PRODUCT ID 694765, IMPLANTED: (B)(6) 2009; IMPLANTABLE PACING LEAD, PRODUCT ID 419478, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER THE IMPLANT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD WAS FOUND TO BE DISLODGED. THE LV LEAD WAS REVISED AND REMAINED IN USE. IT WAS LATER REPORTED THAT THE PATIENT WAS DECEASED APPROXIMATELY EIGHT MONTHS FOLLOWING THE REVISION PROCEDURE DUE TO UNKNOWN CAUSES. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589747 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death