BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1091623 · Received July 31, 2008

    Report

    Report Number
    1644487-2008-01762
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED EXPERIENCING AN EPISODE OF SEVERE CHEST PAIN. THE HOSPITAL PERFORMED A CXR AND INFORMED THE PATIENT THAT "IT LOOKED LIKE IT MAY HAVE BEEN DETACHED." THE PATIENT DID NOT KNOW WHAT WAS MEANT BY THIS STATEMENT, AND WAS REFERRED THE NEUROLOGIST. THE PATIENT ALSO REPORTED EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT'S SEIZURE ACTIVITY LEVEL PRIOR TO BEING IMPLANTED WITH VNS IS UNKNOWN. FOLLOW UP WITH THE NEUROLOGIST REVEALED DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS AND WAS NOT AT END OF SERVICE. THE PT ELECTED TO HAVE THE GENERATOR REPLACED. 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 009342

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R