BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951730 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00088
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 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
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE STYLUS DOES NOT LINE UP WITH THE BUTTONS ON THE DISPLAY, AS A RESULT THE BEZEL OVERLAY ASSEMBLY WAS REPLACED AND THE STYLUS WAS CALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STYLUS PEN OF THE PROGRAMMER DID NOT LINE UP WITH THE BUTTONS TO PRESS. SWITCHING OUT THE PEN DID NOT RESOLVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57279 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1