BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1934664 · Received November 26, 2010

    Report

    Report Number
    1000165971-2010-00989
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 2, 2010
    Manufacturer
    SORIN BIOMEDICA 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (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

    THIS ISSUE WAS OBSERVED WHEN THE PACEMAKER WAS INTERROGATED DURING INSPECTION. WHEN THE INTERROGATION TOOK PLACE, A POPUP MESSAGE, REQUESTING DEVICE INITIALIZATION, WAS DISPLAYED ON THE SCREEN. WHEN THE PACEMAKER WAS REINTERROGATED AGAIN, THE MESSAGE WAS NOT DISPLAYED ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2474

    Patients

    Seq Age Sex Outcome Treatment
    1