BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955516 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01371
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 6949 IMPLANTABLE TACHY LEAD 2007 (B)(6). (B)(4). LEAD REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SLOW UPWARD IMPEDANCE TREND AND ELEVATED CAPTURE THRESHOLD. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58631 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR