BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT

    MDR report key: 2945458 · Received February 1, 2013

    Report

    Report Number
    1000165971-2013-00047
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    UPON DEVICE INTERROGATION ONE YEAR AFTER IMPLANTATION, DEVICE MEMORY (AIDA) WAS NOT POPULATED WITH FOLLOW-UP DATA. INDEED, THE DEVICE WAS INTERROGATED ON (B)(6) 2011, AFTER THE IMPLANTATION PROCEDURE, WHICH SHOULD HAVE ACTIVATED THE RECORDING OF FOLLOW-UP DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45085 ESPRIT NVZ SORIN C.R.M., S.R.L. ESPRIT SR 2548

    Patients

    Seq Age Sex Outcome Treatment
    1