BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2182709 · Received July 8, 2011

    Report

    Report Number
    1000165971-2011-00252
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 5, 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 MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PROGRAMMER WAS CONNECTED TO AN EXTERNAL PRINTER AND RESTARTED. WHEN DEVICE INTERROGATION BEGAN, SOME EGMS WERE PRINTED (CORRESPONDING DEVICE UNK). THE DEVICE WAS THEN FOUND TO BE OPERATING IN VVI PACING MODE WHEREAS IT WAS EXPECTED TO BE IN SAFER PACING MODE. SINCE PT COMPLAINED ABOUT PALPITATIONS, USER REBOOTED THE PROGRAMMER. AFTER REBOOT, DEVICE WAS STILL OPERATING IN VVI PACING MODE, SO IT WAS PROGRAMMED TO SAFER PACING MODE. PRELIMINARY ANALYSIS SHOWED THE VVI PACING MODE RESULTED FROM NOMINAL PARAMETERS PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2387

    Patients

    Seq Age Sex Outcome Treatment
    1