BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2121786 · Received May 20, 2011

    Report

    Report Number
    1000165971-2011-00191
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 9, 2011
    Manufacturer
    SORIN CRM S.R.I.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    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

    THE PACEMAKER INVOLVED IN THIS REPORT WAS IMPLANTED ON (B)(6) 2010. REPORTEDLY, THE PROGRAMMED MODE WAS DDD ON THE FOLLOW UP DATED (B)(6) 2011. WHEN THE PT CAME BACK FOR HIS 3-MONTH F/U ON THE (B)(6) 2011, THE PACING MODE WAS VVI UPON FIRST INTERROGATION, ALTHOUGH NO REPROGRAMMING HAD BEEN PERFORMED BY THE TECHNICIAN IN THE MEANTIME. REPORTEDLY, THERE WAS NO INTERROGATION HISTORY RECORD WHERE DEVICE MODE WAS CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.I. REPLY DR 2481

    Patients

    Seq Age Sex Outcome Treatment
    1