BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 523485 · Received May 5, 2004

    Report

    Report Number
    2182863-2004-00027
    Event Type
    Malfunction
    Date Received
    May 5, 2004
    Date of Event
    September 19, 2003
    Report Date
    May 5, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    KRG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS ORCHESTRA PROGRAMMER WAS USED TO INTERROGATE A PT'S DEVICE IN 2003, HOWEVER IT WAS REPORTED THAT THE UNIT WOULD NOT BOOT UP AND DISPLAYED AN ERROR MESSAGE STATING, "OPERATING SYSTEM NOT FOUND." THIS PROGRAMMER WAS ORIGINALLY REPORTED ON A DEVICE DEFECT REPORT (DDR); HOWEVER, ACCORDING TO THE LETTER DATED APRIL 23, 2004 FROM THE FDA THIS DEVICE IS BEING FILED AS AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORCHESTRA PROGRAMMER KRG ELA MEDICAL, S.A. ORCHESTRA *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other