BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 4090112 · Received September 15, 2014

    Report

    Report Number
    1644487-2014-02346
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    October 2, 2006
    Report Date
    August 18, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY DUE TO SUDEP. THE PHYSICIAN INDICATED THAT VNS DID NOT CAUSE NOR SUSPECTED TO HAVE INVOLVEMENT IN THE CAUSE OF DEATH. THE PHYSICIAN DID NOT HAVE ANY FURTHER INFORMATION REGARDING THE PATIENT'S DEATH. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    AN ADDITIONAL SUDEP EVALUATION WAS PERFORMED BASED ON INFORMATION FROM THE NATIONAL DEATH INDEX, AND THE DEATH WAS DETERMINED TO BE PROBABLE SUDEP. THE CAUSE OF DEATH WAS OTHER AND UNSPECIFIED CONVULSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569761 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 5423

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death