BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1091664 · Received July 31, 2008

    Report

    Report Number
    1644487-2008-01757
    Event Type
    Death
    Date Received
    July 31, 2008
    Date of Event
    June 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT DIED. THE PHYSICIAN REPORTED THAT THE RELATIONSHIP BETWEEN THE DEATH AND VNS WAS UNK, AND THAT THE PT DIED FOLLOWING A SERIES OF SECONDARY GENERALIZED SEIZURES. EVAL BY A NURSE INDICATES THAT THE DEATH WAS NOT SUDEP. IT WAS REPORTED THAT THE DEVICES WERE NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 Death