BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4163422 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02963
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE TOUCH PANEL RESPONDED INCORRECTLY, THE OVERLAY AND THE STYLUS WERE VERIFIED TO BE OUT OF ALIGNMENT AND THE OVERLAY WAS THEREFORE REPLACED. IT WAS FURTHER NOTED THAT THE PROGRAMMER POWERED UP TO A 0502 ERROR AND THE MEDIA PROCESSING UNIT BOARD WAS THEREFORE REPLACED AND THE HARD DRIVE REIMAGED. ANALYSIS ALSO FOUND THAT THE LOWER HANDLE WAS BROKEN, THAT THE SYSTEM FAN HAD A DAMAGED WIRE AND THAT THE NYLON SPACER WAS BROKEN. ALL WERE REPLACED TO RESOLVE. CONCOMITANT PRODUCT: PRODUCT ID 229047, SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PANEL OF THE PROGRAMMER FAILED TO SENSE THE TOUCH CONTROL CORRECTLY AND FAILED TO COMPLETE PROGRAMMING/READING PARAMETERS ON THE PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639300 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD