BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951660 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00078
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    RICE CREEK MFG
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLUS AND CURSOR DO NOT ALIGN; THEREFORE, THE TOUCHPEN CANNOT BE CALIBRATED. TECHNICAL SERVICES RECOMMENDED THAT ANOTHER TOUCHPEN FROM ANOTHER PROGRAMMER BE TRIED. THE STATUS OF THE PROGRAMMER IS UNKNOWN. NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56053 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1