BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3790928 · Received May 5, 2014

    Report

    Report Number
    1644487-2014-01199
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 7, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT'S SEIZURES ARE FIFTEEN TIMES A MONTH AND LAST TWO TO THREE MINUTES. IT WAS NOTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES IN (B)(6) 2013 WITH TWO SEIZURES FOR OVER A WEEK. THE PHYSICIAN INCREASED THE DEVICE OUTPUT CURRENT TO 2MA AND THE PATIENT BECAME SEIZURE FREE AGAIN. THE NOTES INDICATE THAT THE PATIENT HAS EXPERIENCED MORE FREQUENT SEIZURES THAT HAVE CHANGED IN CHARACTER. IT WAS NOTED THAT THERE HAVE BEEN NO RECENT MEDICATION CHANGES. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT'S SEIZURES ARE EVERY OTHER DAY AND ARE SHORTER AND LESS IMPAIRING. THE ASSESSMENT NOTES THAT VNS PLACEMENT AND RUFINAMIDE HAVE HELPED SEIZURES, BUT SHE CONTINUES TO HAVE APPROXIMATELY 8 COMPLEX PARTIAL SEIZURES PER MONTH. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL CLINIC NOTES WERE RECEIVED. THE CLINIC NOTES REPORT THAT SHORTLY AFTER THE VNS SURGERY (IN (B)(6) 2013), THE PATIENT HAD A DIFFERENT SEIZURE PRESENTATION. PATIENT STARES AND PATIENT¿S HEAD WILL OFTEN SLUMP DOWN. NO ARM MOVEMENT WAS OBSERVED. THESE WERE HAPPENING ONCE PER DAY AT VARIOUS TIMES, LASTING ABOUT 3 MIN EACH TIME, AND STARTED SHORTLY AFTER HER SURGERY. THE CLINIC NOTES ALSO REPORT THAT FROM (B)(6) 2013, THE VNS CURRENT WAS AT 1.5MA AND THE PATIENT HAD SEVERAL AURAS BUT NO SEIZURES. THEN THE VNS WAS INCREASED TO 1.75MA ON (B)(6) 2013 AND THE PATIENT HAD 1-2 SEIZURES PER DAY FROM (B)(6) 2013 SO THE VNS WAS DECREASED BACK TO 1.5 PER THE PARENT¿S REQUESTS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE NEUROLOGIST THAT THERE WERE NO MEDICATION CHANGES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE NEW SEIZURE TYPE. PER THE PHYSICIAN, THE NEW SEIZURE TYPE IS NOT LIKELY RELATED TO VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266995 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202207

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention