BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131626 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00997
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: (B)(4): THE PROGRAMMER WAS RETURNED, ANALYZED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT REGARDING THE INTERMITTENT PRINTER FUNCTION. ANALYSIS ALSO FOUND A BROKEN PRINTER DRAWER, ERRORS LOGGED ON THE HARD DRIVE AND A MISSING STYLUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRINTER MALFUNCTIONS AT TIMES. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER KRG MEDTRONIC, INC. 2090 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other