BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2121764 · Received May 20, 2011

    Report

    Report Number
    1000165971-2011-00190
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 2, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011. 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 DEVICE WAS FOUND IN STANDBY MODE UPON A F/U PERFORMED 1 MONTH AND A HALF AFTER IMPLANT. THE PHYSICIAN ASKED FOR CLARIFICATIONS ABOUT THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2500

    Patients

    Seq Age Sex Outcome Treatment
    1