BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4103226 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02411
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    February 16, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY DUE TO AN OPIATE OVERDOSE AND THAT VNS DID NOT CAUSE THE PATIENT'S DEATH. THE PATIENT'S SON ALSO REPORTED THAT THE AUTOPSY REPORT LISTED THE CAUSE OF DEATH AS PROBABLE SEIZURE ASSOCIATED WITH SUDDEN DEATH DUE TO CHRONIC SEIZURE DISORDER DUE TO ENCEPHALOPATHY AND PROBABLE OPIATE OVERDOSE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581629 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3326

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death