BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1131043 · Received August 20, 2008

    Report

    Report Number
    1644487-2008-01962
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT'S GENERATOR HAD MOVED MEDIALLY TOWARDS THE ANTERIOR AXILA LINE AND WAS EXTRUDING THROUGH THE SKIN. THE SURGEON INDICATED SURGERY IS LIKELY TO REPOSITION THE DEVICE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention