BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2172244 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01624
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    July 15, 2006
    Report Date
    June 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A VNS PT PASSED AWAY ON (B)(6) 2006. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 011296

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death