BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990389 · Received August 7, 2014

    Report

    Report Number
    2182208-2014-02251
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 4, 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

    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 LATCH TABS WERE BROKEN OFF THE POWER CORD DOOR AND ALSO FOUND THAT THE SYSTEM FAN WAS INTERMITTENTLY NOISY, THAT IT WAS MISSING HINGE COVERS, THE KEYBOARD LATCH WAS BROKEN, THERE WAS A DAMAGED FOOT PAD ON ITS LOWER CASE AND THAT THE PROGRAMMER WAS OUT OF SPECIFICATION ON SEVERAL FUNCTIONAL TESTS AND THEREFORE THE LINK ELECTRONIC MODULE (LEM) BOARD WAS REPLACED AND CALIBRATED. ALL DEFECTIVE PARTS WERE REPLACED AND THE SOFTWARE WAS RELOADED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S POWER CORD COMPARTMENT WAS BROKEN AND THAT THE FAN MAY HAVE BEEN NOISY. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464857 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090W

    Patients

    Seq Age Sex Outcome Treatment
    1