BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT

    MDR report key: 2065943 · Received March 25, 2011

    Report

    Report Number
    1000165971-2011-00130
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    PRIOR TO AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE, THE PHYSICIAN NOTED THAT THE INTERNAL CIRCUITS SEEMED/FELT DETACHED FROM THE CAN. THEREFORE, THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN CRM S.R.L. ESPRIT S 2502

    Patients

    Seq Age Sex Outcome Treatment
    1