BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2951586 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00066
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    PMA / PMN Number
    P890003/S080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE HAD A BURNT SMELL AT THE BACK OF THE PROGRAMMER NEAR THE POWER SUPPLY, LIKELY DUE TO THE CAUSE OF THE SMOKE COMING FROM THE PROGRAMMER, SMOKE WAS LIKELY DUE TO A KEYBOARD SCREW THAT WAS STUCK INSIDE OF THE POWER SUPPLY. ANALYSIS CONFIRMED THE LONG BOOT TIME SO THE SOFTWARE WAS RELOADED. IT WAS ALSO NOTED THAT THE KEYBOARD WAS MISSING TWO SCREWS, THE SYSTEM FAN WAS NOISY, THE PRINTER WOULD NOT PRINT, AND THE DEVICE WAS MISSING RIGHT KEYBOARD HINGE. PRODUCT ID 229047 ANALYZER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER WAS VERY SLOW TO BOOT UP AND THAT A NURSE AT THE CLINIC ONCE SAW SMOKE COMING FROM THE PROGRAMMER. THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55463 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG 2090

    Patients

    Seq Age Sex Outcome Treatment
    1