BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2813619 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03920
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 30, 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): THE PROGRAMMER WAS RETURNED AND ANALYSIS FOUND THAT THERE WAS A LOOSE ELECTROCARDIOGRAM (ECG) CONNECTOR AND THAT THE PRINTED CIRCUIT BOARD WAS LOOSE OR DETACHED AND THAT THE STYLUS WAS NOT WORKING CORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER NEEDED A UNIVERSAL SERIAL BUS (USB) PORT FIX, THAT IT WOULD NOT READ. IT WAS FURTHER NOTED THAT THE PROGRAMMER ALSO NEEDED A SOFTWARE UPDATE. THE PROGRAMMER WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO INDICATION OF ANY PATIENT INVOLVEMENT ASSOCIATED WITH 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| 2067 PROGRAMMER RF HEAD