BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3992114 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02415
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 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 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 THAT THE DEVICE WAS OUT OF SPECIFICATION ON UPLINK FUNCTIONAL TESTS, AND THE CABLE WAS TWISTED AND WORN. AS A RESULT THE CABLE WAS REPLACED. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN AND THE LABEL WAS MISSING THE LAMINATE BACKING. (B)(4).

    Description of Event or Problem · 1

    THE RADIOFREQUENCY (RF) HEAD 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
    470313 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER, 229047 ANALYZER