BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2033751 · Received February 11, 2011

    Report

    Report Number
    1000165971-2011-00070
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 26, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FEBRUARY 11, 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, OUR TECHNICIAN COMPLAINED THAT WHEN THE AUTOSENSING FEATURE IS ACTIVATED: THE DISPLAY OF THE UNDER SENSING ZONE IS NOT CORRECT ON P WAVE HISTOGRAM. THE PAST P WAVES ARE MISSING IN THE OVERVIEW DATED (B)(6) 2011 BECAUSE THE CURRENT SENSITIVITY DURING THE AIDA READING WAS 2,0 MV. THE PHYSICIAN HAS OBSERVED UNDERSENSING. THE CUSTOMER ASKED CLARIFICATIONS ABOUT SORIN CHOICE TO PRESENT P WAVE HISTOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2493

    Patients

    Seq Age Sex Outcome Treatment
    1