BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2043262 · Received February 25, 2011

    Report

    Report Number
    1000165971-2011-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    June 1, 2010
    Report Date
    February 7, 2011
    Manufacturer
    SORIN C.R.M., 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

    FEB. 25, 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS REPORT WAS INTERROGATED ON (B)(6) 2010. SUSTAINED HIGH VENTRICULAR IMPEDANCE WAS CONFIRMED IN IMPEDANCE TREND CURVE (V LEAD: VITATRON; BRILLIANT S+, IMW15Q/VF0003335 IMPLANTED ON (B)(6) 2000). NO ANOMALY WAS FOUND THROUGH THE DEVICE CHECK. SINCE HIGH IMPEDANCE RECORDS WERE STORED IN AIDA, THE DEVICE WAS CLOSELY EXAMINED. HOWEVER, NO ANOMALY WAS CONFIRMED. IT SHOULD BE NOTED THAT THE PACEMAKER WAS PROGRAMMED IN VDD PACING MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2325

    Patients

    Seq Age Sex Outcome Treatment
    1