BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4830121 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01814
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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 WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT BOOT UP AND DISPLAY THE "DEVICE SELECTION" SCREEN AND WAS UNABLE TO REPLICATE THE ISSUE, THE PROGRAMMER POWERED UP AND WORKED AS EXPECTED. IT WAS NOTED THAT A RECENT LOG ERROR WAS OBSERVED AND THAT THE PROGRAMMER FAILED ITS LINK ELECTRONIC MODULE (LEM) CALIBRATION AND THEREFORE THE LEM BOARD WAS REPLACED AND CALIBRATED, THE HARD DRIVE RECONFIGURED AND THE SOFTWARE RELOADED, AND FURTHER THAT THE TAB ON THE POWER CORD BAY DOOR WAS BROKEN, BOTH THE POWER SUPPLY AND SYSTEM FANS WERE NOISY AND THE KEYBOARD WAS DAMAGED. ALL WERE REPLACED TO RESOLVE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT BOOT UP AND DISPLAY THE "DEVICE SELECTION" SCREEN PRIOR TO A DEVICE CHECK. THE PROGRAMMER WAS TURNED OFF AND CHANGED OUT, AND THEN RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380218 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 R2067L RADIOFREQUENCY PROGRAMMER HEAD