BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2813366 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03890
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    July 23, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    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 RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - RF (RADIO FREQUENCY) HEAD TESTED OUT OF SPECIFICATION ON ELECTROMAGNETIC IMMUNITY FUNCTIONAL TESTS; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. RF HEAD LABEL IS MISSING THE BACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RF (RADIO FREQUENCY HEAD WAS "BROKE." THE RF (RADIO FREQUENCY) HEAD 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
    1 CARELINK PROGRAMMER RF HEAD KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other