BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160890 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02780
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND BOTH LEFT AND RIGHT KEYBOARD HINGES ARE BROKEN. BOTH KEYBOARD RAIL COVERS ARE BROKEN. RELEASE TAB ON THE PRINTER DRAWER IS BROKEN. TAB ON POWER CORD BAY DOOR IS BROKEN. ECG (ELECTROCARDIOGRAM) CONNECTOR ON THE LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY IS LOOSE. SYSTEM FAN IS NOISY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE FITTED KEYBOARD HAS BROKEN LOOSE FOR PROGRAMMER BODY. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642559 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 ANALYZER