BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3993480 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02311
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 WAS NOT ABLE TO CONFIRM THE REPORTED ERRORS, HOWEVER, ERRORS FOUND IN THE PROGRAMMER ERROR LOG. ANALYSIS ALSO FOUND THE SYSTEM FAN IS NOISY. KEYBOARD SCREWS WERE MISSING, HOWEVER, FOUND INSIDE THE PROGRAMMER. STYLUS WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE SYSTEM ERRORS. 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
    468146 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1