BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861225 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07348
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    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
    OTHER

    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: DTBA1D1, ICD, IMPLANTED: (B)(6) 2013; 694765, LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD NO CAPTURE IN THE ATRIUM AND THE PROGRAMMER LONGEVITY IS ESTIMATED AT 1.2 YEARS. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD¿S PACE/SENSE PORTION HAD HIGHER THAN NORMAL THRESHOLDS. THE DEVICE REMAINS IN USE AND THE ATRIAL LEAD AND RV PACE/SENSE PORTION OF THE LEAD WERE REPLACED. THE HIGH VOLTAGE PORTION OF THE RV LEAD REMAINS IN USE. IT WAS NOTED THAT AFTER THE LEADS WERE REPLACED THE DEVICE¿S LONGEVITY WAS NOW SIX-AND-A-HALF YEARS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339294 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 419688 LEAD