BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3153546 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01446
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    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 WOULD FREEZE WHILE BOOTING UP AND THAT A "FATAL" ERROR MESSAGE WOULD GENERATE. THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED . (B)(4).

    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 PRODUCTS: PRODUCT ID 2067 PROGRAMMER RF (RADIO-FREQUENCY) HEAD; PRODUCT ID 2290 PACING SYSTEM ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD FREEZE WHILE BOOTING UP. A "FATAL ERROR" MESSAGE WAS ALSO INDICATED. ALL PERIPHERAL PIECES WERE DISCONNECTED, YET THE PROGRAMMER STILL POWERED TO A BLACK SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD FREEZE WHILE BOOTING UP. A "FATAL ERROR" MESSAGE WAS ALSO INDICATED. ALL PERIPHERAL PIECES WERE DISCONNECTED, YET THE PROGRAMMER STILL POWERED TO A BLACK SCREEN. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258537 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1