BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4832961 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02081
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    April 15, 2015
    Report Date
    April 15, 2015
    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER WAS NOT BOOTING UP AND THE HARD DRIVE WAS THEREFORE RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS WAS UNABLE TO VERIFY THE CUSTOMER COMMENT OF THE PRINTING FADING, WHEN THE PROGRAMMER WAS RETURNED THERE WAS NO PAPER INSTALLED IN THE STRIP CHART RECORDER BUT THE PROGRAMMER WAS ABLE TO PRINT STRIP CHARTS THAT SHOWED NO SIGN OF FADING. IT WAS ALSO NOTED THAT THE DISPLAY HAD AN ABNORMALITY ON THE LEFT SIDE, THAT IT WAS DAMAGED AND THEREFORE THE LIQUID CRYSTAL DISPLAY WAS REPLACED. THE HARD DRIVE HEALTH WAS FOUND TO BE LESS THAN 100% AND THE SYSTEM FAN WAS FOUND TO BE NOISY; THE FAN WAS REPLACED AND THE HARD DRIVE WAS ALSO REPLACED AS A PREVENTIVE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID R2290 SOFTWARE ANALYZER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT BOOT UP AND THAT THE PRINTING WAS FADED. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380682 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD