BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991693 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02116
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 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 COULD NOT REPRODUCE THE REPORTED EVENT, HOWEVER, A SYSTEM ERROR WAS FOUND IN THE PROGRAMMER ERROR LOGS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A ROUTINE PATIENT CLINIC, WHILE POWERING UP THE PROGRAMMER, THE PROGRAMMER CRASHED. AS THE PROGRAMMER SHUT DOWN, A BLUE SCREEN APPEARED JUST PRIOR TO THE CRASH. THE PRINTER PRINTED OUT A FATAL ERROR MESSAGE. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468442 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD