BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3213488 · Received July 9, 2013

    Report

    Report Number
    1644487-2013-02058
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    September 13, 2012
    Report Date
    June 10, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUKIERT A, CUKIERT CM, BURATTINI JA, LIMA AM, FORSTER CR, BAISE C, ET AL. A PROSPECTIVE LONG-TERM STUDY ON THE OUTCOME AFTER VAGUS NERVE STIMULATION AT MAXIMALLY TOLERATED CURRENT INTENSITY IN A COHORT OF CHILDREN WITH REFRACTORY SECONDARY GENERALIZED EPILEPSY. NEUROMODULATION. 2012; E-PUB AHEAD OF PRINT. DOI: 10.1111/J.1525-1403.2012.00522.X

    Description of Event or Problem · 1

    THE ARTICLE, "A PROSPECTIVE LONG-TERM STUDY ON THE OUTCOME AFTER VAGUS NERVE STIMULATION AT MAXIMALLY TOLERATED CURRENT INTENSITY IN A COHORT OF CHILDREN WITH REFRACTORY SECONDARY GENERALIZED EPILEPSY" WAS RECEIVED AND REVIEWED BY THE MANUFACTURER. THE ARTICLE REPORTS THE OUTCOME AFTER VAGUS NERVE STIMULATION IN CHILDREN WITH SECONDARY GENERALIZED EPILEPSY. TWENTY-FOUR CONSECUTIVE CHILDREN WITH LENNOX¿GASTAUT OR LENNOX-LIKE SYNDROME UNDER THE AGE OF 12 YEARS BY THE TIME OF SURGERY, WHO WERE IMPLANTED WITH A VAGUS NERVE STIMULATOR AND HAD AT LEAST TWO YEARS OF POST-IMPLANTATION FOLLOW-UP, WERE PROSPECTIVELY INCLUDED IN THE STUDY. THE GENERATOR WAS TURNED ON USING THE SETTINGS 0.25 MA, 30 HZ, 500 MICROSECONDS, 30 SECONDS ¿ON,¿ 5 MINUTES ¿OFF¿. THE CURRENT WAS THEN INCREASED BY 0.25 MA EVERY TWO WEEKS, UNTIL 3.5 MA WAS REACHED OR ADVERSE EFFECTS WERE NOTED. PARENTS OR CAREGIVERS KEPT A SEIZURE DIARY. A PREIMPLANTATION MEAN (THREE MONTHS) DAILY SEIZURE FREQUENCY WAS OBTAINED, AND THE CHILDREN WERE FOLLOWED UP EVERY TWO MONTHS AFTER STIMULATION PARAMETERS STABILIZATION. THE ANTIEPILEPTIC DRUG DOSAGES WERE KEPT STABLE THROUGHOUT THE STUDY. FREQUENCY AND PULSE DURATION (30 HZ, AND 500 MICROSECONDS, RESPECTIVELY) WERE KEPT STABLE DURING THE STUDY. MAGNETIC RESONANCE IMAGING WAS NORMAL OR SHOWED ATROPHY IN 13 CHILDREN. SIX CHILDREN GOT AN END-OF-STUDY (24 MONTHS) POST-IMPLANTATION VIDEO-ELECTROENCEPHALOGRAM, AND THEIR FINDINGS WERE SIMILAR TO THOSE BEFORE VNS. QUALITY OF LIFE AND HEALTH MEASURES IMPROVED IN UP TO 50% (MEAN = 25%) IN 20 CHILDREN. ATTENTION WAS NOTED TO IMPROVE IN 21 OUT OF THE 24 CHILDREN. FINAL INTENSITY PARAMETERS RANGED FROM 2 TO 3.5 MA (MEAN = 3.1 MA). AN IMPLANTATION EFFECT WAS NOTED IN 14 OUT OF THE 24 CHILDREN, AND LASTED A MEAN OF 20.2 DAYS. THERE WERE 47 SEIZURE TYPES AMONG THE 24 CHILDREN. AN AT LEAST 50% SEIZURE FREQUENCY REDUCTION WAS NOTED IN 35 SEIZURE TYPES AND 17 SEIZURE TYPES DISAPPEARED AFTER VNS. ATYPICAL ABSENCE, MYOCLONIC AND GENERALIZED TONIC-CLONIC SEIZURES WERE SIGNIFICANTLY REDUCED BY VNS; TONIC AND ATONIC SEIZURES DID NOT IMPROVE. TRANSIENT SEIZURE FREQUENCY WORSENING WAS NOTED IN TEN OF THE TWENTY-FOUR CHILDREN, AT A MEAN OF 3.1 MA. THIS SEIZURE FREQUENCY WORSENING WAS POTENTIALLY RELATED TO THE INCREASE IN STIMULATION INTENSITY. IN EACH OF THESE TEN PATIENTS, THE SEIZURE FREQUENCY CAME BACK TO THE PREVIOUS ONE AFTER A 0.5MA DECREASE IN STIMULATION INTENSITY. THE SEIZURE FREQUENCY DECREASED IN ALL OF THESE TEN PATIENTS AFTER THE STIMULI INTENSITY REDUCTION. THIS REPORT CAPTURES THE TRANSIENT SEIZURE FREQUENCY WORSENING OF ONE OF THE PATIENTS. THE PATIENT ALSO EXPERIENCED A ¿HONEYMOON¿ AFFECT, CHARACTERIZED BY AT LEAST 50% SEIZURE REDUCTION IMMEDIATELY AFTER IMPLANTATION WITH THE GENERATOR OFF. BETWEEN THE PATIENTS THAT EXPERIENCED THIS, THE AFFECT LASTED A MEAN OF 20.2 DAYS, RANGING FROM 5 TO 45 DAYS. THE OTHER NINE EVENTS OF TRANSIENT SEIZURE FREQUENCY WORSENING ARE CAPTURED IN THE MANUFACTURER REPORT NUMBERS: 1644487-2013-01989 1644487-2013-02051 1644487-2013-02052 1644487-2013-02053 1644487-2013-02054 1644487-2013-02055 1644487-2013-02056 1644487-2013-02057 1644487-2013-02059 NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312651 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other