BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3172828 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01800
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHILDS NERV SYST. 2013 MAY 17. VAGAL NERVE STIMULATION IN CHILDREN UNDER 12 YEARS OLD WITH MEDICALLY INTRACTABLE EPILEPSY.HEALY S, LANG J, TE WATER NAUDE J, GIBBON F, LEACH P.COLLEGE OF MEDICINE, UNIVERSITY HOSPITAL OF WALES, CARDIFF, UK.

    Description of Event or Problem · 1

    ABSTRACT TO THE FOLLOWING ARTICLE: VAGAL NERVE STIMULATION IN CHILDREN UNDER 12 YEARS OLD WITH MEDICALLY INTRACTABLE EPILEPSY. BY HEALY S, LANG J, TE WATER NAUDE J, GIBBON F, LEACH P. WAS RECEIVED FOR REVIEW. THE ABSTRACT INCLUDES MENTION OF TWO PATIENT'S WHOSE VNS WAS REMOVED DUE TO INFECTION. SECOND PATIENT ADDRESSED IN MEDWATCH REPORT NUMBER: 1644487-2013-01798. ABSTRACT OBJECTIVE: THIS STUDY AIMS TO ASSESS THE EFFICACY AND SAFETY OF VAGAL NERVE STIMULATION (VNS) IN CHILDREN LESS THAN 12 YEARS OLD OPERATED ON AT THE UNIVERSITY HOSPITAL WALES. METHOD: RETROSPECTIVE REVIEW OF PATIENTS UNDERGOING VNS INSERTION, OVER A 3-YEAR PERIOD, WAS UNDERTAKEN. ALL CHILDREN HAD A MINIMUM FOLLOW-UP PERIOD OF 2 YEARS. SIXTEEN PATIENTS WERE IDENTIFIED VIA THE PAEDIATRIC EPILEPSY SURGERY DATABASE. A CASE NOTE REVIEW AND TELEPHONE EVALUATION WAS CONDUCTED. SEIZURE FREQUENCY USING THE MCHUGH CLASSIFICATION WAS THE PRIMARY OUTCOME MEASURE, WITH ANTI-EPILEPTIC DRUG (AED) USE AS A SECONDARY OUTCOME MEASURE. RESULTS: THERE WERE 10 MALES AND 6 FEMALES. THE MEAN TIME WITH EPILEPSY PRIOR TO SURGERY WAS 5.7 YEARS AND THE MEAN AGE AT THE TIME OF SURGERY WAS 7.6 YEARS. OVERALL, NINE (56 %) CHILDREN EXPERIENCED A REDUCTION IN THEIR SEIZURE FREQUENCY OF 50 % OR MORE. OF THESE, FOUR (25 %) HAD A REDUCTION OF MORE THAN 80 %. SEVEN CHILDREN (44 %) HAD NO REDUCTION IN THEIR SEIZURE FREQUENCY, ALTHOUGH TWO OF THESE PATIENTS REPORTED BENEFIT REGARDING SEIZURE CONTROL AND POST-ICTAL RECOVERY. THE VNS SYSTEM WAS REMOVED IN TWO PATIENTS DUE TO INFECTION AND NO BENEFIT, RESPECTIVELY. HALF OF THE COHORT (50 %) REDUCED THE NUMBER OF ANTI-EPILEPTIC DRUGS POST-SURGERY, AND THERE WAS AN OVERALL MEAN REDUCTION OF AED OF 0.5. CONCLUSION: THIS STUDY SUGGESTS THAT VNS IS A SAFE AND EFFECTIVE ADJUVANT THERAPY IN CHILDREN UNDER 12 YEARS OLD, WITH OVER HALF REPORTING SIGNIFICANT BENEFIT. FURTHER STUDIES ARE NEEDED TO ENABLE PREOPERATIVE SELECTION OF PATIENTS IN ORDER TO MAXIMISE THE POTENTIAL BENEFIT. GOOD FAITH ATTEMPTS ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274099 PULSE GEN MODEL UNK PULSE GEN MODEL UNK LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention