BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2093991 · Received May 16, 2011

    Report

    Report Number
    1644487-2011-01089
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [ARTICLE CITATION] SIERRA-MARCOS A, MAESTRO I, RODRIGUEZ-OSORIO X, MIRO J, DONAIRE A, APARICIO J, ET AL. SUCCESSFUL OUTCOME OF EPISODES OF STATUS EPILEPTICUS AFTER VAGUS NERVE STIMULATION: A MULTICENTER STUDY. EUR J NEUROL. 2012;19(9):1219-23. HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/22891774.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC POSTER THAT A VNS PT EXPERIENCED WORSENING SLEEP APNEA AFTER BEING IMPLANTED WITH VNS THERAPY. AT THE MOMENT GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE ABSTRACT OF THE ARTICLE THAT THE POSTER PRESENTATION WAS BASED ON (TITLED 'SUCCESSFUL OUTCOME OF EPISODES OF STATUS EPILEPTICUS AFTER VAGUS NERVE STIMULATION: A MULTICENTER STUDY') WAS RECEIVED; HOWEVER, THE IT HAS NO INFORMATION IN REGARDS TO THE SLEEP APNEA INCIDENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    THE FULL ARTICLE (TITLED "SUCCESSFUL OUTCOME OF EPISODES OF STATUS EPILEPTICUS AFTER VAGUS NERVE STIMULATION: A MULTICENTER STUDY") WAS RECEIVED AND REVIEWED. HOWEVER, THERE WAS NO MENTION OF SLEEP APNEA OR ANY PATIENTS THAT EXPERIENCED SLEEP APNEA IN THE ARTICLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention