BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993975 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02283
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 9, 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 PROGRAMMER TOOK OVER A MINUTE TO SAVE A PORTABLE DATA FILE TO THE UNIVERSAL SERIAL BUS. THE HARD DRIVE WAS RECONFIGURED AND THE SOFTWARE RELOADED. DURING ANALYSIS THE PROGRAMMER FAILED FUNCTIONAL VXI TESTS, AND IT WAS ALSO NOTED THAT SOLDER JOINTS ON THE RADIOFREQUENCY HEAD CONNECTOR ON THE LINK ELECTRONIC MODULE (LEM) BOARD WERE CRACKED. THE LEM BOARD WAS REPLACED AND CALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S UNIVERSAL SERIAL BUS (USB) WAS "VERY VERY" SLOW. 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
    470926 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC INC. 2090AA

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD