BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3911287 · Received July 2, 2014

    Report

    Report Number
    1644487-2014-01680
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    February 3, 2013
    Report Date
    June 5, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE BELIEVED CAUSE OF DEATH WAS SUDEP. HE NOTED THAT THERE WAS NO RELATIONSHIP BETWEEN THE CAUSE OF DEATH AND THE VNS SYSTEM. THE PATIENT PASSED AWAY ON (B)(6) 2013. NO AUTOPSY WAS PERFORMED. THE PATIENT WAS FOUND DEAD AFTER SLEEPING ON THE COUGH WITH HIS ¿LEG AJAR IN THE POSITION IT IS IN AFTER A SEIZURE¿. THE PATIENT¿S CONCURRENT ILLNESS WAS SEVERE CONGENITAL COGNITIVE IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY DUE TO SUDEP. THE RELATIONSHIP OF THE DEATH TO VNS AND 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
    385650 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200795

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death