BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4161062 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02750
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE PROGRAMMER WAS UNABLE TO INTERROGATE CERTAIN DEVICES WHEN THE ¿ALLOW WIRELESS COMMUNICATION¿ BOX IS CHECKED; HARD DRIVE WAS REIMAGED AND SOFTWARE RELOADED TO RESOLVE ISSUE. ANALYSIS ALSO FOUND THE PROGRAMMER WAS UNABLE TO FIND ANY WIRELESS DEVICES DURING FIND PATIENT SEARCHES; RF (RADIO FREQUENCY) TRANSCEIVER FOUND OUT OF ELECTRICAL SPECIFICATION. PARTIAL CUT FOUND IN ANTENNA CABLE BEHIND UPPER HINGE, THE SYSTEM FAN IS NOISY, POWER CORD BAY HAS BROKEN TAB, AND KEYBOARD IS SEPARATING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS INTERMITTENT LOSS OF TELEMETRY REPORTED. THE PROGRAMMER WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642514 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY HEAD