BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1696180 · Received May 20, 2010

    Report

    Report Number
    1644487-2010-01220
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 20, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE FUNERAL HOME THAT THEY HAD A VNS DEVICE THAT NEEDED TO BE RETURNED FOR A PT WHO HAD DIED. THE SITE DID NOT PROVIDE ANY ADDITIONAL INFO ON THE PT OR THE PRODUCT INFO. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO AND EXPLANTED PRODUCT FOR ANALYSIS HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death