BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1551073 · Received November 23, 2009

    Report

    Report Number
    1000165971-2009-00066
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    September 28, 2009
    Report Date
    October 1, 2009
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE US. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. THEREFORE, THE MDR IS BEING SUBMITTED AT THIS TIME. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    CONNECTION ISSUES DURING THE IMPLANTATION PROCEDURE; THEREFORE THE DEVICE WAS NOT IMPLANTED. IN ADDITION, ABSENCE OF VENTRICULAR PACING PULSES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ- PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN BIOMEDICA C.R.M., S.R.L. FACIL DR 2353

    Patients

    Seq Age Sex Outcome Treatment
    1