BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160441 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07979
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BEING LIGHT-HEADED AND HEART RATES BELOW THE LOWER RATE OF THE PACEMAKER. IT WAS NOTED BY REMOTE TRANSMISSION THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD WAS HIGH AND THE PROGRAMMED SAFETY MARGIN WAS INADEQUATE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259513 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| L (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)