BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2854193 · Received December 3, 2012

    Report

    Report Number
    1644487-2012-03170
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 17, 2011
    Report Date
    November 8, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, CLINIC NOTES WERE RECEIVED FROM A VNS TREATING PHYSICIAN DATED (B)(6) 2011, WHICH INDICATED THAT THE PATIENT WAS HAVING MORE DROP SEIZURES IN SCHOOL; THE PATIENT WAS HAVING 2-3 PER DAY. THE MAJORITY OF THE PATIENT'S SEIZURES ARE DROP SEIZURES. PRIOR TO THIS THE PATIENT WAS AVERAGING 1 DROP SEIZURE PER DAY. THE PATIENT'S SEIZURES WERE NOTED TO BE STABLE AND THE MAJORITY OCCUR WHEN SHE IS TIRED IN THE EVENING HOURS. DUE TO THE PATIENT'S WORSENED SEIZURE ACTIVITY, THE PHYSICIAN INCREASED THE PATIENT'S MEDICATION DOSAGE. CLINIC NOTES DATED (B)(6) 2009, STATED THAT THE PATIENT HAD 1 EVENT BUT IT WAS THOUGHT THAT THE PATIENT TRIPPED; IT WASN'T TYPICAL FOR HER SEIZURES. OTHERWISE THE PATIENT'S MOTHER DENIED ANY SEIZURES ON THE (B)(6) 2009 VISIT. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE NURSE PRACTITIONER HAVE BEEN MADE BUT HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN THE NURSE PRACTITIONER REPORTED THAT THE INCREASE IN SEIZURES AS NOT RELATED TO VNS; THE PATIENT'S SEIZURES ARE INTRACTABLE. THE ONLY INTERVENTION TAKEN WAS THAT THE PATIENT'S MEDICATIONS WERE INCREASED. THE INCREASE IN SEIZURE FREQUENCY WAS ABOUT THE SAME AS PRE-VNS BASELINE LEVELS. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE INCREASE IN SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 1952

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other