BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991005 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02196
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE EJECT BUTTON WAS BROKEN AND THE USB PORT WAS ALSO BROKEN. IT WAS ALSO NOTED THAT THE DEVICE POWERED UP WITH AN ERROR, REQUIRING THE REPLACEMENT OF THE DISPLAY FLEX. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A BROKEN EJECT BUTTON ON ITS MEDIA PROCESSING UNIT (MPU). FOLLOW-UP DETERMINED THAT THIS WOULD NOT KEEP THE PROGRAMMER FROM PERFORMING ITS ESSENTIAL FUNCTION, BUT WOULD MAKE IT MORE DIFFICULT TO EJECT THE MODEM. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470817 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY (RF) HEAD, 229047 ANALYZER