BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161816 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02640
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE A SYSTEM ERROR DISPLAYED AND THE PROGRAMMER WOULD NOT BOOT; MPU (MAIN PROCESSOR UNIT) PRINTED CIRCUIT BOARD ASSEMBLY FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE PROGRAMMER HAS MAJOR INTERNAL CORROSION DUE TO PROBABLE LIQUID IMMERSION. (B)(4).

    Description of Event or Problem · 1

    THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640254 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 209031

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD