BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2612163 · Received June 11, 2012

    Report

    Report Number
    2182208-2012-02290
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    March 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED IN PART ON DEVICE RETURN AND ANALYSIS. THE EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. THE PROGRAMMER PASSED ELECTRICAL TESTING, WITH NO RELATED ERROR OR CONNECTION PROBLEM FOUND. SEVERAL ERROR MESSAGES WERE FOUND IN THE PROGRAMMER HISTORY LOGS, AND THE PAINT OF THE BEZEL WAS PEELING OFF IN FOUR DIFFERENT AREAS. (B)(4) ANALYSIS FOUND THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD FAILED ELECTRICAL TESTING, WHICH IS LIKELY RELATED TO THE REPORTED ERROR MESSAGE ADVISING A LOST CONNECTION. THE CABLE WAS OUT OF SPECIFICATION. THE LABEL BACKING WAS ALSO MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER DISPLAYED AN ERROR MESSAGE ADVISING THE CONNECTION WAS LOST. THE PROGRAMMER WAS RETURNED FOR REPAIR. THE PROGRAMMER RF (RADIO-FREQUENCY) HEAD WAS RETURNED WITH THE PROGRAMMER. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAMMER NVZ MEDTRONIC, INC. 2090X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER