BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIX

    MDR report key: 3151902 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05586
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTED: 2007 (B)(6); 5071 LEFT VENTRICULAR (LV) LEAD: 2004 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE ATRIAL LEAD WAS PROGRAMMED OFF PREVIOUSLY DUE TO HIGH IMPEDANCES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252554 SUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5072-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6945 IMPLANTABLE TACHY LEAD