BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2941915 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00276
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD UNCONTROLLED SEIZURES. THE PATIENT HAD MULTIPLE SEIZURES AND WAS ADMITTED TO THE HOSPITAL. HER LAMICTAL LEVEL WAS LOW AND THE DOSE WAS INCREASED AS A RESULT. THE PATIENT ALSO HAD ADDITIONAL SEIZURES BELIEVED TO BE DUE TO THE GENERATOR BEING AT END OF SERVICE BUT THAT WAS LATER DETERMINED THAT THE GENERATOR WAS NOT AT END OF SERVICE. THE PATIENT WAS GIVEN 10 MG OF VALIUM AND DID NOT HAVE A RECURRENCE OF THE SEIZURES. IT IS UNKNOWN IF THE SEIZURES WERE ABOVE OR BELOW PRE-VNS BASELINE OR THE RELATIONSHIP TO VNS. THE PHYSICIAN BELIEVED SOME OF THE REPORTED SEIZURES WERE ACTUALLY PSEUDO-SEIZURES AND THE PATIENT HAS UNDERLYING ANXIETY WHICH CONTRIBUTED TO THEM. THE PATIENT WAS STARTED ON A MEDICATION THAT SHE HAD RESPONDED TO WELL IN THE PAST. THE PATIENT ALSO HAVE A SETTING ADJUSTMENT INCREASED (OUTPUT CURRENT - 3.25 MA, PULSE WIDTH - 500 USEC, ON TIME - 30 SEC, OFF TIME 3 MINUTES) WHICH THE PATIENT TOLERATED WELL. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN FEELS THAT THE PATIENT'S INCREASE IN SEIZURES WERE DUE TO HER DISEASE PROGRESSION. PATIENT WAS REPORTED AT A (B)(6) 2013 APPOINTMENT TO BE HAVING 7-8 SEIZURES A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47320 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2688

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR