BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2812104 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03786
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THEY WERE UNABLE TO PROPERLY NAVIGATE THROUGH THE PROGRAMMING INTERFACE OF THE PROGRAMMER DUE TO A MAJOR TOUCHPEN OFFSET; IN UPPER LEFT CORNER, MORE THAN 2 CM BETWEEN TIP OF TOUCHPEN AND MOUSE CURSOR ON DISPLAY. IT WAS ALSO NOTED THAT CALIBRATION SOFTWARE AND REPLACEMENT OF TOUCHPEN DID NOT IMPROVE NAVIGATION AND RELATED TOUCHPEN OFFSET. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    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