BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3671296 · Received March 10, 2014

    Report

    Report Number
    1644487-2014-00651
    Event Type
    Death
    Date Received
    March 10, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 5, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OKANISHI T, AND FUJIMOTO A. (2017). INSUFFICIENT EFFICACY OF VAGUS NERVE STIMULATION FOR EPILEPTIC SPASMS AND TONIC SPASMS IN CHILDREN WITH REFRACTORY EPILEPSY. EPILEPSY RESEARCH 140 (2018) 66-71. DOI: 10.1016/J.EPLEPSYRES.2017.12.010.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE VNS PATIENT PASSED AWAY FROM SUDEP ON (B)(6) 2014. THE PATIENT WAS FOUND DEAD IN HIS BED BY HIS MOTHER. THE PATIENT HAS A HISTORY OR NOCTURNAL SEIZURES AND FEBRILE SEIZURES. AN AUTOPSY WAS NOT PERFORMED. THE PATIENT WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH, BUT IT IS NOT BELIEVED TO BE RELATED TO THE PATIENT¿S DEATH. THE DEVICE WAS NOT EXPLANTED AND NO DEVICE ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    A RESEARCH ARTICLE COMPRISED OF DATA FROM A HOSPITAL'S STUDY OF EFFICACY FOR PEDIATRIC VNS PATIENTS IMPLANTED BETWEEN DECEMBER 2010 AND MAY 2015 WAS RECEIVED. WITHIN THE ARTICLE, IT WAS REPORTED THAT TWO PATIENTS' DATA WAS EXCLUDED FROM THE STUDY DUE TO ONE PATIENT DEATH DURING THE MONITORING PERIOD AND ONE PATIENT INFECTION PREVENTING THE PATIENT FROM CONTINUING WITH VNS. CLARIFICATION RECEIVED FROM THE PHYSICIAN INDICATED THAT THE DEATH AND INFECTION HAD PREVIOUSLY BEEN REPORTED TO THE MANUFACTURER, AND THE PROVIDED PATIENT IDENTIFIERS ALIGNED WITH THE REPORT OF PATIENT DEATH CAUSED BY SUDEP CAPTURED IN THIS REPORT. THE REPORTED INFECTION IS DISCUSSED IN MFR. REPORT # 1644487-2013-03225. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142108 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201513

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death