BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6327063 · Received February 13, 2017

    Report

    Report Number
    1644487-2017-03196
    Event Type
    Death
    Date Received
    February 13, 2017
    Date of Event
    January 22, 2009
    Report Date
    March 7, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE FUNERAL HOME WHERE SERVICES WERE PERFORMED PROVIDED THE CAUSE OF DEATH AS AN ACCIDENTAL DROWNING, DUE TO SEIZURE. THE DEATH OCCURRED WITHIN AN INTERVAL OF 3 DAYS. AN AUTOPSY WAS NOT PERFORMED. THE SEIZURE OCCURRED (B)(6) 2009 AT HOME. THE PATIENT HAD A SEIZURE IN THE BATHTUB WHICH RENDERED THE PATIENT UNCONSCIOUS. A NEAR DROWNING OCCURRED, BUT THE PATIENT WAS DECLARED BRAIN DEAD. AN ESTIMATE OF BATTERY LIFE USING THE MANUFACTURER¿S IN-HOUSE PROGRAMMING HISTORY DATABASE ESTIMATED THE BATTERY HAD 7.0 YEARS UNTIL END-OF-SERVICE AT THE TIME OF THE PATIENT¿S DEATH, AND WAS EXPECTED TO BE FUNCTIONING AT THE TIME OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A COMPANY REPRESENTATIVE BY A MEDICAL PROFESSIONAL THAT A VNS PATIENT WAS DECEASED. AN ONLINE OBITUARY SEARCH IDENTIFIED THE DATE OF DEATH AS (B)(6) 2009. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108604 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 8814

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death