BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2864998 · Received December 10, 2012

    Report

    Report Number
    2183613-2012-02051
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DXY
    PMA / PMN Number
    P890003/S065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE DEVICE PRINTED AND SAVED TO USB AS REQUIRED WITH NO ISSUES. HOWEVER, THE DEVICE WAS STUCK IN A LONG BOOT, SO IT DOES GO TO A BLACK SCREEN INTERMITTENTLY DURING BOOT UP. IT WAS ALSO NOTED THAT THE SYSTEM FAN WAS NOISY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER PRINTER WAS PRINTING VERY SLOWLY AND THAT SAVING TO THE UNIVERSAL SERIAL BUS (USB) WAS ALSO VERY SLOW. IT WAS FURTHER REPORTED THAT UPON BOOT-UP IT WENT TO A BLACK SCREEN AND REFERENCED "BEING LOCKED." THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO INDICATION GIVEN AS TO ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER PRINTER WAS PRINTING VERY SLOWLY AND THAT SAVING TO THE UNIVERSAL SERIAL BUS (USB) WAS ALSO VERY SLOW. IT WAS FURTHER REPORTED THAT UPON BOOT-UP IT WENT TO A BLACK SCREEN AND REFERENCED "BEING LOCKED." THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO INDICATION GIVEN AS TO ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC MILACA, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIO FREQUENCY PROGRAMMER HEAD