BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON DA+ C-SERIES SR

    MDR report key: 4162914 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02499
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    August 5, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REPRESENTATIVE COULD NOT INTERROGATE THE PACEMAKER. THREE DIFFERENT PROGRAMMERS WERE USED, BUT ALL GAVE THE SAME ERROR MESSAGE. THE DEVICE REMAINS IN USE WITH NO PLANNED INTERVENTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640170 VITATRON DA+ C-SERIES SR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C10A3U

    Patients

    Seq Age Sex Outcome Treatment
    1