BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153250 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05908
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH 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. 5076 IMPLANTABLE PACING LEAD 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNDERSENSING OBSERVED PREVIOUSLY IN THE RIGHT ATRIAL LEAD AND THAT THE PATIENT'S RHYTHM FREQUENTLY GOES INTO ATRIAL FIBRILLATION. A PROGRAMMING INQUIRY REGARDING SENSING ASSURANCE WAS MADE AND IT WAS RECOMMENDED TO LEAVE THE SENSING ASSURANCE PROGRAMMED ON. THE 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
    255113 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)