BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 3990931 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02203
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 23, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE RF (RADIO FREQUENCY) HEAD FAILED UPLINK FUNCTIONAL TESTS AND WAS NOT ABLE TO INTERROGATE; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. THE RF HEAD LABEL IS MISSING THE BACK COATING AND THE RF HEAD UPPER CASE LENS IS CRACKED. (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
    469522 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1 2090 PROGRAMMER