BEUDAMED
    FDA Adverse Event Death Summary report: N

    MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE 2/28/05,

    MDR report key: 514545 · Received March 6, 2004

    Report

    Report Number
    1644487-2004-00167
    Event Type
    Death
    Date Received
    March 6, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 5, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    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) 2004 AND THE PATIENT¿S CAUSE OF DEATH WAS POTENTIAL SUDEP, WITH EPILEPSY, UNSPECIFIED, SEQUELAE OF INTRACRANIAL INJURY, AND SEQUELAE OF OTHER ACCIDENTS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF DEFINITE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    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) 2004 AND THE PATIENT¿S CAUSE OF DEATH WAS POTENTIAL SUDEP, WITH EPILEPSY, UNSPECIFIED, SEQUELAE OF INTRACRANIAL INJURY, AND SEQUELAE OF OTHER ACCIDENTS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF DEFINITE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE 2/28/05, LYJ CYBERONICS, INC. 102 7811

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE 2/28/05,| MEDICATIONS AT TIME OF DEATH INCLUDE: VALPROATE /| VALPROIC ACID, PHENYTOIN, GABAPENTIN.| DATE OF MFG 2/24/2003, STERILIZATION LOT NO. 7910.