BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 2945454 · Received February 1, 2013

    Report

    Report Number
    1000165971-2013-00046
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    KRG
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, DURING A FOLLOW-UP PERFORMANCE ON (B)(6) 2013, IT WAS NOTICED THAT THE IMPLANT MODEL WAS NOT RECOGNIZED BY THE PROGRAMMER AND THEREFORE CLASSIFIED AS "UNK". AT THE END OF THE SESSION, IT WAS NOT POSSIBLE TO EXPORT THE FOLLOW-UP ELECTRONIC REPORT. AN EXPLANATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44173 ORCHESTRA KRG SORIN CRM S.R.L. ORCHESTRA PLUS 0

    Patients

    Seq Age Sex Outcome Treatment
    1