BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 3207072 · Received July 5, 2013

    Report

    Report Number
    2182208-2013-01870
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCTS: ADDL1 IMPLANTABLE PULSE GENERATOR (IPG) 2008-11-10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LOSING CAPTURE WHEN THE PATIENT WAS LYING ON THE LEFT SIDE. NO CHANGES HAVE BEEN MADE AND THE 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
    307982 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR