BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK PROGRAM W/TELEMETRY C

    MDR report key: 2791273 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03504
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 12, 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): THE PROGRAMMER WAS RETURNED AND ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE DEVICE WOULD OCCASIONALLY NOT POWER ON. THE DEVICE WAS TURNED OFF AND BACK ON AND FUNCTIONALLY TESTED AND NO FAULT WAS FOUND. A STAPLE WAS FOUND IN THE UNIVERSAL SERIAL BUS (USB) PORT. THERE WAS A NOISY SYSTEM FAN WHICH WAS REPLACED AND A BROKEN RIGHT KEYBOARD HINGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WOULD OCCASIONALLY NOT POWER UP. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT INVOLVEMENT WAS INDICATED FOR 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