BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 2888894 · Received December 21, 2012

    Report

    Report Number
    1000165971-2012-00506
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SORIN CRM 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

    DECEMBER 21, 2012 - THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PROGRAMMER SOFTWARE UPGRADE TO (B)(4) VERSION FAILED EVEN AFTER SEVERAL ATTEMPTS. AN EXPLANATION WHETHER THE UPGRADE WAS FINALLY SUCCESSFUL OR NOT IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORCHESTRA KRG SORIN CRM S.R.L. ORCHESTRA

    Patients

    Seq Age Sex Outcome Treatment
    1