BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2813607 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03917
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 27, 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. 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. IT IS NOTED THAT THE REPORTED WIRELESS COMMUNICATION ISSUES WERE DUE TO THE "ALLOW WIRELESS" RADIAL DIAL NOT BEING SELECTED ON THE PROGRAMMER. (B)(4): NO TELEMETRY WITH THE RF (RADIO FREQUENCY) HEAD; RF HEAD CABLE FOUND OUT OF ELECTRICAL SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROGRAMMER HAD ISSUES WITH WIRELESS COMMUNICATION. THE PROGRAMMER WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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