BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2790243 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03436
    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 THAT THE SOFTWARE WAS UNABLE TO BE UPDATED. ANALYSIS ALSO FOUND THAT A TAB WAS MISSING FROM THE POWER CORD BAY, THE KEYBOARD SLIDE COVER WAS MISSING AND THE KEYBOARD WAS NOT INSTALLED, THE ELECTROCARDIOGRAM (ECG) CONNECTOR WAS LOOSE AND THE USER WAS UNABLE TO SELECT OBJECTS ON THE SCREEN USING THE STYLUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ATTEMPTS TO UPDATE THE PROGRAMMER SOFTWARE VIA THE SDN (SOFTWARE DISTRIBUTION NETWORK) WERE UNSUCCESSFUL. THE PROGRAMMER WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    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 2067 PROGRAMMER RF HEAD