BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4162979 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-03035
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 6, 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

    THIS REPORT IS BASED SOLELY ON DEVICE 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER HAD A BROKEN SCREEN AND THEREFORE THE DISPLAY OVERLAY WAS REPLACED AND CALIBRATED. ANALYSIS ALSO FOUND A LOOSE STYLUS CONNECTOR AND AN INTERMITTENT FLOPPY DRIVE AND THEREFORE THE MEDIA PROCESSING UNIT PRINTED CIRCUIT BOARD WAS REPLACED AS WELL AS THE FLOPPY DRIVE AND THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A BROKEN SCREEN. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639620 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 SOFTWARE ANALYZER