BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160857 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02790
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE PROGRAMMER STYLUS PEN CANNOT BE CALIBRATED. STYLUS AND ARROW DO NOT ALIGN. CAN SELECT, BUT IT IS DIFFICULT DUE TO IT IS OFF ABOUT A INCH AND A HALF. OVERLAY FOUND OUT OF ELECTRICAL SPECIFICATION. CONCOMITANT MEDICAL PRODUCTS: 229047, ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER STYLUS PEN CANNOT BE CALIBRATED. THE STYLUS PEN WAS CHANGED TO A NEW PEN AND THE CALIBRATION PROGRAM RAN THREE TIMES AND IT STILL IS OFF. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642228 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD