BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON

    MDR report key: 3062168 · Received April 16, 2013

    Report

    Report Number
    9614453-2013-00991
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    September 18, 2012
    Report Date
    February 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DURING ROUTINE FOLLOW-UP IT WAS DISCOVERED THAT THE DEVICE HAD A SOFTWARE RESTORE LAST YEAR. AFTER THE RESET THE DEVICE RESTORED TO THE PROGRAMMED SETTINGS AS BEFORE. IT WAS NOTED THAT THE PATIENT HAD RECEIVED CT (COMPUTED TOMOGRAPHY) IMAGING LAST YEAR. 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
    163871 VITATRON PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C70A3U

    Patients

    Seq Age Sex Outcome Treatment
    1