BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2811972 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03742
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SYSTEM ERROR DISPLAYED ON THE PROGRAMMER SCREEN WHEN THE PROGRAMMER WAS POWERED ON. THE POWER WAS CYCLED SEVERAL TIMES AND THE ERROR NEVER CLEARED. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER NVZ MEDTRONIC, INC. 2090X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other