BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 4160864 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02781
    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 CONFIRMED THE REPORTED EVENT; RF (RADIO FREQUENCY) HEAD HAS NO TELEMETRY AND FAILED ALL UPLINK AMPLITUDE FUNCTIONAL TESTS. RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE RF HEAD LENS IS CLOUDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS POOR/INCONSISTENT TELEMETRY. THE RF (RADIO FREQUENCY) HEAD 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
    640915 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2067L

    Patients

    Seq Age Sex Outcome Treatment
    1