BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2903591 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00105
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2009
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED AN INCORRECT EVENT DATE.

    Description of Event or Problem · 1

    A MANUSCRIPT TITLED "EFFICACY OF VAGUS NERVE STIMULATION IN INTRACTABLE EPILEPSY PATIENTS IN CYPRUS" WAS RECEIVED BY THE MANUFACTURER FOR REVIEW. THE ARTICLE DISCUSSES EFFICACY OF VNS OVER TIME, WHICH WAS ANALYZED IN 27 PATIENTS. TWO PATIENTS DIED OF SUDDEN UNEXPECTED DEATH IN EPILEPSY (SUDEP). DATE OF DEATH UNKNOWN AND RELATIONSHIP TO VNS IS UNKNOWN. THE REPORT OF THE OTHER PATIENT WHO DIED OF SUDDEN UNEXPECTED DEATH IN EPILEPSY (SUDEP) IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00104. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE REPORT OF ONE PATIENT WHO DEVELOPED AN INFECTION IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00102. THE REPORT OF ONE PATIENT WHO HAD VNS EXPLANTED DUE TO DYSPHAGIA ASSOCIATED WITH VNS STIMULATION IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00103. THE REPORT OF ONE FOCAL PATIENT WHO HAD WORSENING OF SEIZURES IS REPORTED IN MFG REPORT NUMBER: 1644487-2013-00101. THE VNS EXPLANT DUE TO PAINFUL STIMULATION IN THE NECK IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00100.

    Description of Event or Problem · 1

    THE ARTICLE TITLED " SUDDEN UNEXPECTED DEATH IN EPILEPSY: EXPERIENCE FROM A TERTIARY EPILEPSY CENTER IN CYPRUS WITH REVIEW OF THE LITERATURE" WAS RECEIVED BY THE MANUFACTURER AND REVIEWED. THE PATIENT DIED ON THE BEACH DURING THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12560 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death