BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6052726 · Received October 24, 2016

    Report

    Report Number
    1644487-2016-02456
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    December 11, 2014
    Report Date
    January 19, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMMUNICATIONS WITH THE OFFICE OF THE TREATING PHYSICIAN SHOWED THAT THE LAST APPOINTMENT THEY HAD WITH THE PATIENT WAS ON (B)(6) 2007. ATTEMPTS FOR ADDITIONAL PERTINENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH AN ONLINE OBITUARY THAT THE PATIENT PASSED AWAY ON (B)(6) 2014 IN HIS HOME. NO INFORMATION ON THE CAUSE OF DEATH OR RELATION TO VNS WAS STATED AT THE TIME OF THE REPORT. ATTEMPTS FOR ADDITIONAL PERTINENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE COUNTY CORONER REPORTED WITH INFORMATION OF THE CIRCUMSTANCES OF THE PATIENT¿S DEATH. THE PATIENT DIED AT HIS RESIDENCE. HIS RECENT MEDICAL HISTORY INDICATED HYPERTENSION AND PNEUMONIA, AND HIS DEATH WAS SIGNED OUT AS ¿NATURAL CAUSES¿. DUE TO THE LACK OF SUSPICIOUS ISSUES INVOLVED, AN AUTOPSY WAS NOT ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701580 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014188

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death