BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951401 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00019
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 5, 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 THE REPORTED EVENT. THE CALIBRATION AND STYLUS ISSUES WERE DUE TO THE OVERLAY ASSEMBLY BEING OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE LEFT KEYBOARD HINGE WAS BROKEN, AND THE HARD DRIVE WAS RECONFIGURED AND SOFTWARE WAS RELOADED DUE TO A LONG BOOT TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER HAD CALIBRATION AND STYLUS ISSUES. IT WAS NOTED THAT IT MAY BE DISPLAY-SCREEN RELATED. IT WAS FURTHER REPORTED THAT THE PROGRAMMER HAD A SLOW START, ABOUT 30 SECONDS LONGER THAN NORMAL. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55498 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 2067 RADIOFREQUENCY (RF) HEAD