BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3050992 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04783
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 6949 IMPLANTABLE TACHY LEAD (B)(6) 2005; 1258T86 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS ATRIAL UNDERSENSING. IT WAS NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH FAST CONDUCTED BEATS TO THE VENTRICLE. THE PATIENT REPORTED BEING ABLE TO FEEL IT. THE RIGHT ATRIAL (RA) 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
    149217 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR