BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2201674 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01190
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) ANALYSIS FOUND THAT THE PROGRAMMER BOOTED UP WITH A WHITE SCREEN AND WOULD NOT ADVANCE ANY FURTHER. THE CURSOR APPEARED ON THE SCREEN AND WAS RESPONSIVE TO THE STYLUS PEN. THE CAUSE OF THE REPORTED BEHAVIOR COULD NOT BE DETERMINED, HOWEVER, RELOADING THE SOFTWARE CORRECTED THE ISSUE. THE PROGRAMMER FACE PLATE WAS ALSO NOTED TO HAVE ONE LOOSE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS STUCK ON A VITATRON SCREEN. THE SERVICE DISK WAS RUN, BUT AFTER THAT, THE PROGRAMMER BOOTED TO A BLANK SCREEN. 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 PROGRAMMER KRG MEDTRONIC, INC. 2090 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other