BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964840 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01976
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT: 4194 IMPLANTABLE PACING LEAD (B)(6) 2007; 6947 IMPLANTABLE DEFIB LEAD (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD IMPEDANCE WAS HIGH YET STABLE AT 1950 OHMS. IT WAS ALSO REPORTED THAT AT A ROUTINE CHANGEOUT, THE LEAD WAS INSERTED INTO THE NEW DEVICE AND THE IMPEDANCE MEASURED 1030 OHMS. THRESHOLDS WERE STABLE 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
    67135 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR