BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1051741 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01221
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A PT PROTRUSION OF THE LEAD BODY, INCREASED SEIZURES, PAIN AND PAINFUL STIMULATION SECONDARY TO A BAD COLD WHERE SHE EXPERIENCED SEVERE COUGHING, SNEEZING, AND VOMITING. THE PT UNDERWENT SURGERY AND THE PT'S VAGUS NERVE WAS FOUND TO BE BENT AT AN ANGLE AND ATTACHED TO THE JUGULAR VEIN. THE SURGEON PROVIDED MORE STRAIN RELIEF IN THE NECK AND STRAIGHTENED THE NERVE. THE PT'S GENERATOR WAS ALSO REPLACED PROPHYLACTICALLY.

    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 Hospitalization| R