BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2131609 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00993
    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) ANALYSIS CONFIRMED THE REPORTED EVENT. THE PROGRAMMER POWERED UP WITH A SYSTEM ERROR. THE STYLUS AND THE POWER CORD DOOR WERE ALSO FOUND TO BE BROKEN, AND THE SYSTEM FAN WAS MAKING LOUD NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER HAD A BLACK SCREEN AND SERIOUS PROBLEM ERROR. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    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 2290 PACING SYSTEM ANALYZER