BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 2972321 · Received February 15, 2013

    Report

    Report Number
    1000165971-2013-00066
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 4, 2013
    Manufacturer
    SORIN BIOMEDICA S.R.L.
    Product Code
    KRG
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2013, SOME INFORMATION IN THE PATIENT SCREEN WAS MISSING UPON PRINTING. THIS OBSERVATION WAS NOTED AT THE IMPLANTATION PROCEDURE WITH TWO DIFFERENT PACEMAKERS. AN EXPLANATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69845 ORCHESTRA KRG SORIN BIOMEDICA S.R.L. ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1