BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160830 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02787
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INTERROGATION ISSUE; ABLE TO INTERROGATE DEVICES MULTIPLE TIMES WITH NO FAULT FOUND. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED SOFTWARE UPGRADE ISSUE. ANALYSIS FOUND THE STYLUS DOES NOT FUNCTION, STYLUS FOUND OUT OF ELECTRICAL SPECIFICATION. KEYBOARD CABLE SEPARATING AT CONNECTOR; KEYBOARD CABLE FOUND DAMAGED. PROGRAMMER DISPLAY DROPS; LOWER DISPLAY HINGES FOUND DAMAGED. PROGRAMMER FAILED CHART RECORDER TEST; PRINTER FOUND OUT OF ELECTRICAL SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER HEAD WAS UNABLE TO PICK UP DEVICES INTERMITTENTLY. THE PROGRAMMER AND PROGRAMMER HEAD WERE 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
    642220 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD