BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2131781 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-01024
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT. THE PROGRAMMER RF HEAD FAILED TESTING, AND THE CABLE WAS FOUND TO BE OUT OF SPECIFICATION. THE MAGNET WAS ALSO BROKEN. (B)(4): THE PROGRAMMER RF HEAD FAILED TESTING, AND THE CABLE WAS FOUND TO BE OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO ESTABLISH TELEMETRY WITH THE PROGRAMMER RF HEAD (B)(4). NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. PROGRAMMER RF HEAD (B)(4) WAS RETURNED WITH THE PROGRAMMER AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO ESTABLISH TELEMETRY WITH THE PROGRAMMER RF HEAD. 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 RF HEAD KRG MEDTRONIC, INC. 2067 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2090W PROGRAMMER