BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3892221 · Received June 24, 2014

    Report

    Report Number
    1644487-2014-01576
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSES AWAY ON (B)(6) 2014. THE CAUSE OF DEATH IS BELIEVED TO BE SUDEP AND NOT RELATED TO VNS. AN AUTOPSY WAS NOT PERFORMED. THE PATIENT EXPERIENCED SEIZURE REDUCTION WITH VNS. THE PATIENT DIED ON HIS BED AND HIS DEATH WAS NOT WITNESSED. THE PATIENT DID NOT HAVE A HISTORY OF FEBRILE SEIZURES BUT DID HAVE A HISTORY OF NOCTURNAL SEIZURES. THE PATIENT DID NOT HAVE A HISTORY OF DRUG/ALCOHOL ABUSE OR CARDIAC/RESPIRATORY PROBLEMS. IT WAS REPORTED THAT THE PATIENT WAS COMPLIANT WITH HIS MEDICATIONS. THE PATIENT HAD SIMPLE PARTIAL AND SECONDARY GENERALIZED SEIZURES AND HAD RESECTIVE SURGERY IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368421 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202436

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death