BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2790413 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03456
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE LEFT KEYBOARD HINGE WAS BROKEN, THE PRINTER DOOR HANDLE WAS GONE AND THE PAPER GUIDE WAS MISSING, THE SLIDE COVER RAILS FOR THE KEYBOARD SLIDE PLATE WERE BENT, THE UPPER AND LOWER CASE HANDLES OF THE PROGRAMMER WERE BROKEN, THE SYSTEM FAN WAS NOISY AND THE STYLUS PEN DID NOT PLUG ALL THE WAY INTO THE CONNECTION OF THE MAIN PROCESSING UNIT CIRCUIT BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOOR TO THE RADIO FREQUENCY HEAD COMPARTMENT IS BROKEN. ALSO, THE PRINTER TRAY HANDLE/RELEASE IS BROKEN RESULTING IN DIFFICULTY IN REMOVING TO REPLACE PAPER. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other