BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2811245 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03756
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE SCREEN HAD COLORED LINES AND REMAINED BLANK. THE FLEX TAPE WAS MISALIGNED TO THE LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO BOOT UP TO THE MAIN SCREEN, THAT THE SCREEN REMAINED BLACK. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH 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 2067 PROGRAMMER RF HEAD| 2290 PACING SYSTEM ANALYZER