BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3991157 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02182
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 29, 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: DURING ANALYSIS THE PROGRAMMER FAILED THE EMERGENCY KEY TEST DUE TO THE EMERGENCY CABLE CONNECTOR NOT BEING FULLY CONNECTED TO THE XY BOARD AND THEREFORE THE EMERGENCY CABLE CONNECTOR WAS RESEATED. NO OTHER ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS RETURNED FOR REPAIR. FOLLOW-UP DETERMINED THAT THE REPRESENTATIVE MENTIONED A "GLITCH" BUT AS THAT REPRESENTATIVE IS NO LONGER WITH THE COMPANY NO FURTHER INFORMATION IS AVAILABLE. THE PROGRAMMER HAS BEEN RETURNED TO SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EXTERNAL 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
    472122 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY PROGRAMMER HEAD