BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951818 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00090
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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 CONFIRMED THE REPORTED EVENT, THE STYLUS PEN WAS NOT TRACKING WITH THE OVERLAY SCREEN. IT WAS ALSO NOTED THAT THE BEZEL WAS PEELING, AS A RESULT THE OVERLAY SCREEN ASSEMBLY WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLUS AND THE "ARROW" ARE APART FROM EACH OTHER ON THE PROGRAMMER DISPLAY. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56489 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RF HEAD, 2290 ANALYZER