BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMER

    MDR report key: 2952823 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00236
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 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

    (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 PEN FOR THE PROGRAMMER WAS NOT CALIBRATED AND MEAURED 1.5" OFF. THE CALLER INQUIRED ON HOW TO CALIBRATE IT. TECHNICAL SERVICES INSTRUCTED THE CALLER ON HOW TO INSTALL THE CALIBRATION SOFTWARE, AS THE DISK WAS NOT AVAILABLE, AND CALIBRATE THE PEN. THE PEN AND PROGRAMMER REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55925 PROGRAMMER PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090XS

    Patients

    Seq Age Sex Outcome Treatment
    1