BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON

    MDR report key: 2965099 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00336
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    June 27, 2012
    Report Date
    December 17, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PARTIAL RESET AS INDICATED BY THE ERROR MESSAGE ON THE PROGRAMMER. IT WAS NOTED THAT AFTER THE RESET THE DEVICE RESTORED TO THE PROGRAMMED SETTINGS VIA THE BACKUP AND DIAGNOSTICS HAD BEEN RESTARTED. NO FURTHER ACTION IS REQUIRED AND THE DEVICE 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
    69345 VITATRON PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C60A3U

    Patients

    Seq Age Sex Outcome Treatment
    1