BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 2926989 · Received January 18, 2013

    Report

    Report Number
    1000165971-2013-00024
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 30, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    KRG
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    JANUARY 18, 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE OF THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, AN ERROR MESSAGE WAS DISPLAYED AFTER THE PROGRAMMER SOFTWARE WAS UPGRADED TO (B)(4) VERSION. AN EXPLANATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27350 ORCHESTRA KRG SORIN C.R.M., S.R.L. ORCHESTRA PLUS 0

    Patients

    Seq Age Sex Outcome Treatment
    1