BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991107 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02189
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 27, 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 THERE WAS A DAMAGED POWER CORD BAY AND IT WAS THEREFORE REPLACED. ANALYSIS ALSO FOUND THAT THE PROGRAMMER HAD A LONG BOOT TIME AND THE SOFTWARE WAS THEREFORE RELOADED AND ALSO THAT THE PROGRAMMER FAILED MULTIPLE FUNCTION TESTS AND THEREFORE THE LINK ELECTRONIC MODULE BOARD WAS REPLACED. THE PROGRAMMER THEN PASSED ALL FUNCTIONAL AND SYSTEMS TESTS AND NO OTHER ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD A DAMAGED BAY ASSEMBLY FOR THE POWER CORD. 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
    468044 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD