BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992070 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02430
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 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, AS A RESULT THE LINK ELECTRONIC MODULE (LEM) CIRCUIT BOARD WAS REPLACED AND CALIBRATED. IT WAS ALSO NOTED THAT THE LEFT AND RIGHT LOWER DISPLAY HINGES WERE OUT OF SPECIFICATION, AND THE HARD DRIVE WAS RECONFIGURED AND SOFTWARE WAS RELOADED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RF (RADIO FREQUENCY) HEAD PORT IS POSSIBLY DYSFUNCTIONING. THE RF HEAD CABLE HAS TO BE HELD UP IN ORDER FOR IT TO WORK. SEVERAL DIFFERENT HEADS WERE TRIED WITH THE SAME RESULT. THE PROGRAMMER WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469213 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1