BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051077 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04746
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4): P1501DR IMPLANTABLE PULSE GENERATOR 2009-(B)(6); (B)(4) IMPLANTABLE PACING LEAD 2009-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATRIAL AND VENTRICULAR LEADS HAD A DECREASE IN P AND R-WAVES. THE ATRIAL LEAD WAS REPOSITIONED AND REMAINS IN USE AND THE VENTRICULAR 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
    148435 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R