BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161060 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02746
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING AN INTERROGATION OF A DEVICE, THE GREEN LIGHTS 'SCROLLED UP AND DOWN' BUT WERE UNABLE TO INTERROGATE THE DEVICE. ANOTHER PROGRAMMER WAS USED. THE PROGRAMMER WILL BE RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642402 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090EN

    Patients

    Seq Age Sex Outcome Treatment
    1