BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1013898 · Received March 14, 2008

    Report

    Report Number
    1644487-2008-00699
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT DIED. VNS GENERATOR AND LEAD WERE EXPLANTED FROM PT AND PRODUCT ANALYSIS IS PENDING. FURTHER ATTEMPTS FOR INFO ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O