BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2952465 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00174
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HARD DRIVE WAS OUT OF ELECTRICAL SPECIFICATION. THE DISPLAY OVERLAY/BEZEL ASSEMBLY WAS REPLACED AND CALIBRATED AND THE HARD DRIVE WAS CONFIGURED AND SOFTWARE WAS LOADED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROGRAMMER HAD BEEN RETURNED FOR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WILL NOT BOOT UP TO THE MAIN SCREEN. OF NOTE, WHEN THE PROGRAMMER WAS POWERED ON, IT "LOCKED UP" AT THE "HOUR GLASS" SCREEN AND WOULD NOT GO BEYOND THIS SCREEN. THE CALLER RAN THE SERVICE DISKETTE AND GOT AN ERROR MESSAGE. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56753 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD