BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN

    MDR report key: 1013709 · Received March 13, 2008

    Report

    Report Number
    1644487-2008-00695
    Event Type
    Death
    Date Received
    March 13, 2008
    Date of Event
    January 1, 2005
    Report Date
    February 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SHE WAS INFORMED BY A STAFF MEMBER AT THE TREATING NEUROLOGIST'S OFFICE THAT A YOUNG FEMALE VNS PATIENT DIED SHORTLY AFTER VNS IMPLANTATION APPROXIMATELY 3 YEARS AGO. NO OTHER INFORMATION WAS AVAILABLE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE TREATING MEDICAL PROFESSIONAL HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other