BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3992145 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10037
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 MEDICAL PRODUCTS: 506852 LEAD, IMPLANTED: (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD HAS INCREASED AND IS HIGH AND OUT OF RANGE. THE P WAVES HAVE DECREASED, BUT THE THRESHOLD IS STABLE. THE LEAD REMAINS IN USE WITH PROGRAMMING OPTIONS DISCUSSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471444 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR E2DR01AA IPG