BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2830042 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02978
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS FEELING WORSE THAT SHE DID BEFORE BEING IMPLANTED TO VNS AND WOULD LIKE TO HAVE HER VNS REMOVED. IT IS UNKNOWN WHAT SPECIFIC EVENTS ARE OCCURRING THAT IS CAUSING HER TO FEEL WORSE. SHE CONTACTED THE IMPLANTING SURGEON BUT HE WAS CONCERNED ABOUT TAKING IT OUT. IT WAS DETERMINED WHILE ATTEMPTING TO FOLLOW-UP WITH THE PATIENT'S NEUROLOGIST OFFICE SHE SAW AFTER IMPLANT THAT HE WAS NO LONGER WITH THE PRACTICE (B)(6) 2011. THE PATIENT HAS BEEN LET GO FROM THEIR CARE AND IT WAS UNKNOWN WHO THE PATIENT WAS SEEING. THEY WERE UNABLE TO PROVIDE ANY INFORMATION. ATTEMPTS FOR MORE INFORMATION FROM THE PATIENT HAVE ALSO BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2738

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention