BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1081463 · Received July 25, 2008

    Report

    Report Number
    1644487-2008-01708
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT'S LEAD WAS PROTRUDING. SURGERY TO REPOSITION VNS WAS PERFORMED. DURING SURGERY A NEW POCKET WAS CREATED, AND THE GENERATOR AND LEAD WERE REPOSITIONED IN THE CHEST. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention