BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2792496 · Received October 16, 2012

    Report

    Report Number
    1644487-2012-02631
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2012 WHEN THE PHYSICIAN REPORTED THAT THE INCREASE IN SEIZURES WAS NOT ASSOCIATED WITH VNS; IT WAS RELATED TO A HIGH LEVEL OF VALPROIC ACID. THE PHYSICIAN ADJUSTED THE VALPROIC ACID LEVEL AND THE PATIENT IS FINE NOW.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY. SYSTEM DIAGNOSTICS WERE REPORTED TO BE FINE AND A NORMAL MODE DIAGNOSTICS SHOWED DCDC=6. THE PATIENT'S SEIZURE ACTIVITY WAS STATED TO HAVE INCREASED APPROXIMATELY FIVE-FOLD. ON (B)(6) 2012, THE NURSE REPORTED THAT THE PATIENT WAS COMING IN THAT DAY FOR ASSESSMENT. THEY DID A DRUG LEVEL AND IT WAS HIGH SO THERE IS NO ROOM TO ADJUST MEDICATIONS FOR A TEMPORARY SOLUTION. THE PATIENT'S MOTHER INDICATED SINCE THEIR LAST APPOINTMENT ON (B)(6) 2012, THE PATIENT'S SEIZURE ACTIVITY HAS INCREASED. HOWEVER, SHE SAID THE GROUP HOME INDICATED IT STARTED JUST PRIOR TO THE APPOINTMENT. ON THE CLINIC NOTES THEY INDICATED ONE SEIZURE EVERY 5 WEEKS AND CURRENTLY HE IS HAVING A TONIC/CLONIC SEIZURE EVERY 5-7 DAYS. THE SETTINGS AT THE LAST VISIT WERE OUTPUT=2.5MA AND OUTPUT=2.75MA FOR NORMAL AND MAGNET MODE RESPECTIVELY. THEY WERE BOTH INCREASED BY 0.25MA. NORMAL MODE DIAGNOSTICS SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=6/NEOS=NO WHEN THE DEVICE WAS PROGRAMMED TO NORMAL MODE OUTPUT=2.75MA. THE ONLY INTERVENTIONS ONE WERE TO TALK TO THE MOTHER AND GROUP HOME FOR COMPLETE DETAILS AND DO A BLOOD DRUG LEVELS TO SEE IF ADJUSTMENTS COULD BE MADE AND TO BRING THE PATIENT IN FOR EVALUATION. IT WAS LATER REPORTED ON (B)(6) 2012 THAT SINCE THE REDUCTION LAST WEEK, THURSDAY, THERE IS NO IMPROVEMENT IN SEIZURE ACTIVITY. THE PHYSICIAN IS CONSIDERING A MEDICATION CHANGE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 5.57YEARS REMAINING UNTIL ERI=YES. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN MADE BUT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2276

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention