BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2790479 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03460
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    June 5, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    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) ECG (ELECTROCARDIOGRAM) CONNECTOR IS LOOSE ON A PRINTED CIRCUIT BOARD ASSEMBLY. OVERLAY TO SCREEN IS CRACKED. SYSTEM FAN IS NOISY. TAB FROM CORD BAY IS BENT. HANDLE IS BROKEN. (B)(4) RF (RADIO FREQUENCY) HEAD IS OUT OF SPECIFICATION ON UPLINK FUNCTIONAL TESTS. THE RF HEAD CABLE IS DAMAGED (INSULATION DAMAGE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT THE PROGRAMMER FELL OVER ON ITS CART AND THE HANDLE AND THE SCREEN NEED REPAIR. THE PROGRAMMER AND RF (RADIO FREQUENCY) HEAD WERE RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2290 PACING SYSTEM ANALYZER