BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1081366 · Received July 24, 2008

    Report

    Report Number
    1644487-2008-01704
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAD DECREASED. THE AUTOPSY REPORT STATES THERE WAS "A WITNESSED SEIZURE WHILE SWIMMING." THE VNS DEVICE HAS BEEN EXPLANTED AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. A PREVIOUS MEDWATCH REPORT (1644487-2006-00319) WAS SUBMITTED FOR THE PATIENT'S LEAD, INDICATING HIGH IMPEDANCE WAS OBSERVED IN 2006. AS THE VNS SYSTEM WAS NEVER REPLACED, THE PATIENT WAS NOT RECEIVING VNS THERAPY AT THE TIME OF DEATH. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101

    Patients

    Seq Age Sex Outcome Treatment
    1 Death