BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2043270 · Received February 25, 2011

    Report

    Report Number
    1000165971-2011-00084
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    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

    DURING A F/U ON (B)(6) 2011, THE PHYSICIAN OBSERVED THAT THE STATISTICS DISPLAYED INCONSISTENT DATA: ATRIAL SENSING WAS OVER 100%, VENTRICULAR SENSING AT 77% IN THE OVERVIEW SCREEN BUT AT 0% IN THE AIDA SCREEN. THE PHYSICIAN ASKED FOR AN EXPLANATION OF THE REPORTED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2491

    Patients

    Seq Age Sex Outcome Treatment
    1