BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2964719 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02006
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 27, 2010
    Report Date
    November 27, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. CONCOMITANT PRODUCTS: 6948 IMPLANTABLE TACHY LEAD 2006 (B)(6); 4193 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCE MEASUREMENTS AND WAS BELIEVED TO BE FRACTURED. THE SYSTEM WAS REPROGRAMMED TO A VVIR-MODE AND THE LEAD WAS ELECTRICALLY ABANDONED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66672 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention 7304 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)