BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2000405 · Received February 18, 2011

    Report

    Report Number
    1644487-2011-00296
    Event Type
    Death
    Date Received
    February 18, 2011
    Date of Event
    January 3, 2005
    Report Date
    January 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A VNS PATIENT HAD DIED. THE NURSE DID NOT HAVE ANY FURTHER INFORMATION AT THE TIME OF REPORT. FOLLOW-UP WAS MADE BY A COMPANY REPRESENTATIVE WITH THE NURSE. INFORMATION RECEIVED INDICATED THE PATIENT HAD DIED FROM A SEIZURE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 NONE LYJ CYBERONICS, INC. 102 009157

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death