BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160950 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02768
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 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 REPORTED EVENT; PROGRAMMER HAS A SYSTEM ERROR EVERY TIME A USB (UNIVERSAL SERIAL BUS) MEMORY STICK IS CONNECTED INTO EITHER PORT. HARD DRIVE RECONFIGURED AND SOFTWARE RELOADED AND UPDATED TO RESOLVE ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER CRASHES ANYTIME A USB (UNIVERSAL SERIAL BUS) MEMORY STICK IS CONNECTED. THIS HAPPENED WITH A BLANK MEMORY STICK AND ALSO A PROGRAMMER UPDATE MEMORY STICK. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641064 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1