BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1031152 · Received April 18, 2008

    Report

    Report Number
    1644487-2008-00953
    Event Type
    Death
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT HAD DIED. THE CAUSE OF DEATH AND THE RELATIONSHIP OF THE DEATH TO THE VNS IS UNK. IT IS UNK IF THE PT WAS BURIED WITH THE VNS. ALL ATTEMPTS TO THE REPORTER REGARDING THE DEATH HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 12890

    Patients

    Seq Age Sex Outcome Treatment
    1 Death