BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993211 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02336
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 13, 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 THE CUSTOMER COMMENT THAT THE CORD DOOR AND THE HINGE NEEDED TO BE FIXED, THE LATCH TABS ON THE CORD DOOR WERE BROKEN OFF, THE LOWER CASE WAS BROKEN NEAR THE HANDLE AREA AND THE LEFT KEYBOARD HINGE WAS BROKEN, ALL WERE REPLACED. IT WAS FURTHER NOTED THAT THE PROGRAMMER BOOTED TO AN ERROR AND THE XY BOARD WAS REPLACED TO RESOLVE, AND THAT THE HARD DRIVE WAS NOISY AND IT WAS ALSO REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S CORD DOOR AND HINGE NEEDED REPAIR AND IT WAS FURTHER REQUESTED THAT THE PROGRAMMER BE CHECKED FOR SAFETY. 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
    468907 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1