BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2131590 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00987
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) IT WAS CONFIRMED THE PROGRAMMER BOOTED UP TO THE SCREEN WITH MEDTRONIC LOGO AND NO FURTHER. SOFTWARE ERRORS FOUND. LOWER CASE HANDLE FOUND BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER WOULD NOT BOOT. IT WAS STUCK ON THE BLACK MEDTRONIC SCREEN. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PROGRAM W/TELEMETRY C PROGRAMMER DXY MEDTRONIC, INC. 2090W ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2067 PROGRAMMER RF HEAD