BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860794 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05288
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 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: 6947, IMPLANTABLE TACHY LEAD, (B)(6) 2012; 4196, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLD HAD BEEN HIGH FOR SOME TIME. AFTER MITRAL VALVE SURGERY THERE WAS LOSS OF ATRIAL CAPTURE AND INTERMITTENT ATRIAL SENSING. THE DEVICE WAS PROGRAMMED TO VVI WITH VENTRICULAR SENSE RESPONSE. THE RA LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338759 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR