BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2201161 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00281
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 22, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DEVICE WAS IMPLANTED AND PROGRAMMED IN VVI MODE WITH A 80 MIN-1 BASIC RATE MODE AT 15:30. AROUND 19:00, THE DEVICE WAS FOUND IN STANDBY MODE. THE DEVICE WAS FINALLY REINITIALIZED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY SR 2497

    Patients

    Seq Age Sex Outcome Treatment
    1