BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1111874 · Received August 12, 2008

    Report

    Report Number
    1644487-2008-01874
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    March 19, 2008
    Report Date
    August 11, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT OR PRODUCT PROBLEM CORRECTED DATA: LEAD MALFUNCTION ISSUE WAS INADVERTENTLY REPORTED ON MDR # 1644487-2008-01012 INSTEAD OF BEING REPORTED AS AN INITIAL MDR. DEVICE MALFUNCTION IS SUSPECTED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT'S VNS SYSTEM WAS REPLACED BECAUSE IT WAS "MALFUNCTIONING". ATTEMPTS FOR FURTHER INFO FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE. THIS INFO WAS ORIGINALLY REPORTED IN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1142

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR