BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990900 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02205
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT VERIFY THE STYLUS / OVERLAY ISSUE; ABLE TO CALIBRATE AND OPERATE STYLUS / OVERLAY WITH NO ISSUES. ANALYSIS COULD NOT VERIFY INTERROGATION ISSUES WITH THE PROGRAMMER, HOWEVER, THE RF (RADIO FREQUENCY) HEAD FAILED UPLINK FUNCTIONAL TESTS WHICH WOULD LIKELY BE THE CAUSE OF THE REPORTED INTERROGATION ISSUE. ANALYSIS FOUND THE FLOPPY DRIVE HAD INTERMITTENT FUNCTIONALITY PROBLEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TOUCH PEN WAS NOT WORKING. THE PEN WAS REPLACED AND UNABLE TO CALIBRATE IT. IT WAS ALSO REPORTED THE PROGRAMMER HAD TROUBLE INTERROGATING DEVICES. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471090 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD