BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1080724 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01683
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    March 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT UNDERWENT SURGERY DURING WHICH THE GENERATOR WAS REPOSITIONED DUE TO A "PINCHING" SENSATION. ATTEMPTS FOR 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 7342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention