BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2895521 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00038
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    June 6, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S SEIZURES HAD GRADUALLY WORSENED OVER THE LAST 6 MONTHS. THE PATIENT WAS PREVIOUSLY ON THE KETOGENIC DIET WHICH WORKED EXTREMELY WELL, BUT HAS BEEN OFF THE DIET NOW FOR ABOUT TWO YEARS. VNS SETTINGS AND MEDICATIONS WERE ADJUSTED. IT WAS NOTED THAT THE PATIENT IS HAVING ABOUT 20 BRIEF STARING SPELLS, WHICH THE PHYSICIAN ASSUMES ARE ATYPICAL ABSENCE SEIZURES, EACH DAY. THE PATIENT IS ALSO HAVING MYOCLONUS EVERY FEW MINUTES THROUGHOUT THE DAY AND THESE ARE AT TIMES VERY FORCEFUL. THE PATIENT'S SETTINGS WERE NOTED TO BE OUTPUT=1.5MA/ON TIME=30SEC/OFF TIME=3MIN. THE PHYSICIAN RECEIVED A WARNING THAT FREQUENT MONITORING DUE TO END-OF-BATTERY-LIFE WOULD BE NEEDED, ALTHOUGH THE VNS WAS STILL FUNCTIONING. IT WAS LATER REPORTED THAT THE PATIENT WOULD BE REFERRED FOR GENERATOR REPLACEMENT AS THE DEVICE IS NEARING END OF SERVICE (IFI=YES) AND THE PATIENT IS HAVING AN INCREASE IN SEIZURES. IT IS UNKNOWN WHETHER OR NOT THE PATIENT'S WORSENED SEIZURES ARE ABOVE THE PATIENT'S PRE-VNS BASELINE. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2012. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS; HOWEVER, ANALYSIS HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ANALYSIS OF THE PULSE GENERATOR REVEALED THAT THE DEVICE WAS IFI = YES. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200746

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other| R