BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993377 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02319
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 17, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE PROGRAMMER OPERATION IS VERY SLOW. PRINTS OUT IN SMALL SPURTS OR NOT AT ALL; MPU (MICROPROCESSOR UNIT) PRINTED CIRCUIT BOARD ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE ECG (ELECTROCARDIOGRAM) CONNECTOR ON LEM (LINK ELECTRONIC MODULE) PRINTED CIRCUIT BOARD ASSEMBLY HAS A FRACTURED SOLDER JOINT. CASE IS CRACKED NEAR HANDLE AREA, SYSTEM FAN AND HARD DRIVE ARE NOISY, RIGHT KEYBOARD HINGE IS BROKEN, AND PRINTER DRAWER IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WORKS FINE, PRINTER IS BROKEN. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469059 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 229047 ANALYZER