BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3153671 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01458
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH PEN FOR THE PROGRAMMER WAS OUT OF CALIBRATION. IT WAS FURTHER REPORTED THAT THE TOUCH PEN WAS RIGHT IN CERTAIN AREAS OF THE SCREEN, BUT WAS AN INCH OR TWO OFF IN OTHER AREA AND RECALIBRATING THE TOUCH PEN DID NOT CORRECT THE ISSUE. THE PROGRAMMER WAS RECOMMENDED TO BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255922 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1