BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153150 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05846
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING. VENTRICULAR LEAD IMPEDANCE STEADILY RISING FROM APPROXIMATELY 500 OHMS IN (B)(4) 2012 TO OVER 1000 OHMS IN (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDR01 IMPLANTABLE PULSE GENERATOR 2008-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAS BEEN A GRADUAL INCREASE IN BOTH THE IMPEDANCES AND THE THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. THE OUTPUT ON THE DEVICE WAS REPROGRAMMED WITH THE ADAPTIVE CAPTURE SETTINGS TURNED TO MONITOR ONLY 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
    256106 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention 5076 IMPLANTABLE PACING LEAD