BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160961 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02764
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 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 WAS NOT ABLE TO REPLICATE THE REPORTED EVENT THAT THE PROGRAMMER DISPLAYED SYSTEM ERROR MESSAGE DURING THE BOOT UP PHASE; THE PROGRAMMER BOOTED TO MEDTRONIC SOFTWARE VERSION 2.7. HOWEVER, A SYSTEM ERROR WAS FOUND IN THE PROGRAMMER ERROR LOGS. ANALYSIS FOUND THE TAB ON THE POWER CORD BAY DOOR IS BROKEN. THE PROGRAMMER FAILED LEFT ANTENNA CONNECTED TEST; THE LEFT ANTENNA CABLE FOUND DAMAGED. PRODUCTS: 229047 ANALYZER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE DURING THE BOOT UP PHASE. THE PROGRAMMER HAS BEEN RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642331 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD