BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1993904 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00246
    Event Type
    Death
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE IN HOSPICE THAT A VNS PT WAS ABOUT TO PASS AWAY DUE TO A SEIZURE DISORDER AND WANTED TO DISABLE THE PATIENT'S DEVICE. FURTHER INFO WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATING SHE WAS NOTIFIED BY THE PATIENT'S FAMILY THAT HE PASSED AWAY ON (B)(6) 2011. ADDITIONAL INFO WAS RECEIVED FROM THE FUNERAL HOME AT WHICH THE PT WAS TAKEN, AND INFO FROM THE FUNERAL HOME INDICATED THAT THE GENERATOR WAS TO BE REMOVED AND GIVEN TO THE PATIENT'S FAMILY. AT THE MOMENT, THE PATIENT'S CAUSE OF DEATH IS UNK AS WELL AS RELATIONSHIP TO VNS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200604

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Death