BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2790181 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03430
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS CONFIRMED THE REPORTED EVENT, THERE WAS A LONG BOOT UP TIME. IT WAS NOTED THAT THE PRINTED CIRCUIT BOARD NEEDED TO BE REPLACED. IT WAS ALSO NOTED THAT THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE, AND THERE WAS A GREEN LINE DOWN THE RIGHT SIDE OF THE DISPLAY. (B)(4): ANALYSIS FOUND THAT THE DEVICE FAILED THE ELECTROMAGNETIC FIELD IMMUNITY TEST AND THE CABLE WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD AN EXTREMELY LONG BOOT-UP TIME. THE PROGRAMMER AND PROGRAMMER HEAD WERE RETURNED TO THE MANUFACTURER, 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 KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER