BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2915530 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00010
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    July 26, 2011
    Report Date
    December 19, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. 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

    REPORTEDLY, ON (B)(6) 2012 FOLLOW UP, SOME OBSERVATIONS WERE NOTED WITH A PT SUFFERING FROM ATRIAL FLUTTER WITH FMS (FALLBACK MODE SWITCH) ALGORITHM ACTIVATED. THE PACING RATE AND OPERATING MODE OF THE DEVICE WHEN EXITING THE TESTS (WHETHER SENSITIVITY OR PACING TEST) WERE NOT EXPECTED: WHILE THE BASIC RATE WAS AT 50 MIN-1, IT STATED TO PACE AT 90 MIN-1 AT THE END OF THE TEST. AN EXPLANATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15052 REPLY NVZ SORIN CRM S.R.L. REPLY D 2511

    Patients

    Seq Age Sex Outcome Treatment
    1