BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 102

    MDR report key: 4100049 · Received September 18, 2014

    Report

    Report Number
    1644487-2014-02375
    Event Type
    Death
    Date Received
    September 18, 2014
    Date of Event
    February 2, 2010
    Report Date
    August 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE NATIONAL DEATH INDEX (NDI) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2010 AND THE PATIENT'S CAUSE OF DEATH WAS CONFIRMED TO BE DOCUMENTED AS INFANTILE CEREBRAL PALSY (UNSPECIFIED), PNEUMONITIS DUE TO FOOD AND VOMIT, AND OTHER AND UNSPECIFIED CONVULSIONS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF POTENTIAL SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Description of Event or Problem · 1

    THE CAUSE OF DEATH WAS LISTED AS INFANTILE CEREBRAL PALSY, PNEUMONITIS DUE TO FOOD AND VOMIT, UNSPECIFIED CONVULSION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. THE RELATIONSHIP OF THE VNS TO THE CAUSE OF DEATH IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578504 MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 12890

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death