BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3990689 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02230
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    February 14, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT, THE DEVICE WAS MECHANICALLY INTACT AND PASSED ALL INCOMING FUNCTIONAL TESTS WITH NO ANOMALIES FOUND. A FUNCTIONAL TEST WAS PERFORMED TWICE ON THE TEST SYSTEM, NO FAILURE OR DEVIATION FOUND. P AND R WAVE OUTPUT WAS MEASURED ON AN ATRIAL AND VENTRICULAR BIPOLAR LEAD, AND IMPEDANCE WAS MEASURED ON AN ATRIAL AND VENTRICULAR UNIPOLAR LEAD, ALL MEASUREMENTS WERE WITHIN SPECIFICATION. ALSO PASSED A SYSTEMS TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANALYZER WAS NOT PROVIDING ¿GOOD¿ ELECTROCARDIOGRAMS (ECGS) FOR PACEMAKER PROGRAMMING. ALTHOUGH, THERE WERE NO ASSOCIATED PATIENT COMPLICATIONS, THE PATIENT HAD TO BE BROUGHT BACK IN AGAIN TO BE REVIEWED AND RE-ANALYZED ON ANOTHER PACEMAKER ANALYZER. THE ANALYZER WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471962 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 229047

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention