BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993418 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02312
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE STYLUS PEN IS NOT TRACKING WITH OVERLAY SCREEN; OVERLAY FOUND OUT OF ELECTRICAL SPECIFICATION. CONCOMITANT PRODUCT: 229047 ANALYZER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PACEMAKER IMPLANTATION, THE PROGRAMMER TOUCH PEN SUDDENLY LOST ITS FUNCTION. THE PROGRAMMER WAS RESTARTED AND THE TOUCH PEN REINSERTED BUT THIS WAS DONE IN VAIN. FURTHERMORE, A NEW TOUCH PEN HAD BEEN CHANGED ONTO THE PROGRAMMER BUT IT STILL DID NOT WORK. THE PROGRAMMER WAS 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
    469312 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD