BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6082539 · Received November 7, 2016

    Report

    Report Number
    1644487-2016-02577
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 15, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE PATIENT PASSED AWAY DUE TO SUSPECTED SUDEP. PER AN OBITUARY, THE PATIENT DIED SUDDENLY IN HER RESIDENCE ON (B)(6) 2016. THE PATIENT WAS FOUND DECEASED IN THE BED AT HOME BY HER PARENTS. PER THE RECORDED PROGRAMMING HISTORY DATA AND AUTOMATIC BATTERY LIFE CALCULATION, IT IS LIKELY THE DEVICE WAS DELIVERING THERAPY AT THE TIME OF THE PATIENT'S DEATH. THE DEVICE WAS EXPLANTED AFTER THE PATIENT'S DEATH. THE GENERATOR HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734537 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS - HOUSTON 103 3332

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death