BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 1081542 · Received July 25, 2008

    Report

    Report Number
    1644487-2008-01722
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED VNS WAS OPENED, BUT WAS NOT UTILIZED BECAUSE IT WAS DEFECTIVE. F/U WITH THE SURGEON REVEALED THE LEAD WAS PLACED IN THE PT'S VAGUS NERVE, BUT THE ELECTRODE KEEP FALLING OFF OF THE NERVE. A SECOND LEAD WAS USED AND EVERYTHING WORKED WELL. THE HANDHELD HAS BEEN RETURNED TO THE MFR AND IS PENDING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 303 MUZ CYBERONICS, INC. 303-20 1686

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR