BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160598 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02819
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 16, 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 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 RF (RADIO FREQUENCY) HEAD FAILED UP LINK FUNCTIONAL TESTS; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND A BROKEN MAGNET, RUST ON THE MAGNET AND ANTENNA COIL, AND BROKEN PRINTED CIRCUIT BOARD ASSEMBLY INSULATOR SHIELD. (B)(4).

    Description of Event or Problem · 1

    THE RF (RADIO FREQUENCY) HEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641177 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1