BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2235440 · Received September 6, 2011

    Report

    Report Number
    1644487-2011-02089
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 15, 2011
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS'; EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT'S MOTHER STATED THAT THE PATIENT NEEDED GENERATOR REPLACEMENT. THE MOTHER BELIEVED THAT THE GENERATOR DEAD SINCE HE BEGAN HAVING AN INCREASE IN SEIZURES (B)(6) 2011 AFTER THEY HAD BEEN WELL CONTROLLED FOR YEARS. PATIENT'S PARTNER OF MULTIPLE YEARS HAD PAST AWAY SHORTLY BEFORE THE INCREASE IN SEIZURES BEGAN. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT. THE PATIENT HAD BEEN HAVING 2 SEIZURES EVERY 6 MONTHS TO HAVING 4 SEIZURES EVERY 6 MONTHS WHICH WAS STILL BELOW PRE-VNS BASELINE. THE CAUSE OF THE INCREASE IN SEIZURES NOT RELATED TO VNS. THE PATIENT HAD A DEATH IN THE FAMILY AND IS UNDER INCREASED STRESS THAT IS THE BELIEVED CAUSE OF THE INCREASE IN SEIZURES. PATIENT DIAGNOSTIC WERE WITHIN NORMAL LIMITS. THE PATIENT HAD THEIR SETTINGS INCREASED AND A PROPHYLACTIC GENERATOR REPLACEMENT IS PLANNED BUT HAS NOT OCCURRED TO DATE. THE PATIENT ALSO HAD A MEDICATION ADDED TO HIS REGIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 35576C

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention