BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 4163522 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02637
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    December 14, 2012
    Report Date
    September 16, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A COPY OF THE DEATH CERTIFICATE WAS RECEIVED WHICH INDICATED THAT CAUSE OF DEATH AS ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO ASPIRATION PNEUMONIA. FOLLOW-UP WITH THE PHYSICIAN INDICATED THAT THE PATIENT¿S DEATH WAS NOT RELATED TO VNS. THE PATIENT ACHIEVED SEIZURE REDUCTION WITH VNS AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. THE PATIENT WAS COMPLIANT WITH HER MEDICATIONS. BASED ON THE AVAILABLE INFORMATION ABOUT THE PATIENT¿S DEATH, AN INTERNAL CLASSIFICATION HAS DETERMINED THAT THE DEATH WAS UNLIKELY SUDEP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2012. THE CAUSE OF DEATH IS BELIEVED TO BE DUE TO ASPIRATION. THE RELATIONSHIP BETWEEN THE DEATH AND VNS IS UNKNOWN. NO FURTHER INFORMATION RELEVANT TO THE PATIENT¿S DEATH HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639251 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2656

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death