BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161438 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02695
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 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

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE PROGRAMMER ERRORED OFTEN HOWEVER ONE ERROR WAS FOUND IN THE ERROR LOG AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS RECALIBRATED, THE HARD DRIVE WAS REIMAGED AND RECONFIGURED AND THE SOFTWARE WAS RELOADED TO CLEAR THE ERROR. IT WAS FURTHER NOTED THAT THE STYLUS TIP WAS LOOSE AND THEREFORE THE STYLUS WAS REPLACED AND CALIBRATED, THAT THE BOTTOM "FEET" OF THE LOWER CASE WERE WORN, THE TOP HINGE PLATE WAS WORN AND BOTH WERE REPLACED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (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 ERRORED OFTEN. FOLLOW-UP DETERMINED THAT THE ERRORS OCCURRED BOTH DURING THE BOOTING PROCESS AND SOMETIMES AFTERWARD. THE PROGRAMMER WAS 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
    641378 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1