BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1960328 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01024
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 7, 2010
    Manufacturer
    SORIN BIOMEDICAL 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

    DECEMBER (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW-UP OF THE DEVICE INVOLVED IN THIS REPORT, SOME INCONSISTENCIES WERE OBSERVED IN THE FOLLOW-UP DATA STORED IN DEVICE MEMORY (AIDA): A TOTAL TIME IN MODE SWITCH (ALGORITHM TO PREVENT HIGH RATE PACING IN THE VENTRICULAR CHANNEL IN CASE OF ATRIAL ARRHYTHMIAS) OF 69 DAYS WAS DISPLAYED , BUT THERE WAS NO CORRESPONDING EPISODE RECORDED IN DEVICE MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICAL CRM S.R.L. REPLY DR 2397

    Patients

    Seq Age Sex Outcome Treatment
    1