BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161050 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02751
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 26, 2014
    Report Date
    July 26, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER WOULD NOT BOOT UP, IT POWERED UP WITH A GRAY SCREEN FOR OVER HALF AN HOUR AND THEN BOOTED TO A 2188065 ERROR. THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. ANALYSIS ALSO FOUND THAT THE TAB ON THE POWER CORD BAY DOOR WAS BROKEN AND THE BAY WAS REPLACED. PRODUCT ID 229047 SOFTWARE ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT BOOT UP, THAT ITS SCREEN WAS JUST BRIGHT. 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
    642537 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD