BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2952744 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00217
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PROGRAMMER DISPLAYED A MESSAGE ERROR AT BOOT-UP. IT WAS NOTED THAT THE PROBLEM SELF-CLEARED AT REBOOT. TE CHNICAL SUPPORT (TS) SUGGESTED THAT THE PROGRAMMER BE SENT IN FOR SERVICE IF THE ISSUE CONTINUES TO OCCUR. THE PROGRAMMER REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57327 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1