BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 6164189 · Received December 9, 2016

    Report

    Report Number
    2182208-2016-02883
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    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

    MANUFACTURER'S ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE PROGRAMMER'S STYLUS COULD NOT BE CALIBRATED TO THE TOUCH SCREEN. IT WAS ALSO INDICATED THAT THE POWER CORD BAY WAS BROKEN. THESE PARTS WERE REPLACED AND THE PROGRAMMER PASSED FINAL FUNCTIONAL AND SYSTEM TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS COULD NOT BE CALIBRATED TO THE TOUCH SCREEN. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812249 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067L RADIOFREQUENCY HEAD