BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3151961 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05573
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    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. CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD - 2008 (B)(6); (B)(4) IMPLANTABLE TISSUE VALVE - 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD A RISE IN IMPEDANCE AND NOISE. THE CAPTURE THRESHOLD HAD A SLIGHT RISE FROM THE PREVIOUS MEASUREMENT. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD CONTINUED TO EXHIBIT AN INCREASE IN IMPEDANCES AND HIGH THRESHOLDS. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN THRESHOLDS. THE LEADS WERE REPROGRAMMED, AND REMAIN 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
    252699 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER