BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 842073 · Received April 25, 2007

    Report

    Report Number
    1644487-2007-00241
    Event Type
    Other
    Date Received
    April 25, 2007
    Date of Event
    January 1, 2007
    Report Date
    February 2, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH OCCURRED, BUT IS NOT SUSPECTED TO BE RELATED TO VNS THERAPY. DEVICE MALFUNCTION IS NOT SUSPECTED.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT INDICATING THAT AN EPILEPSY PATIENT HAD "PASSED AWAY". IT WAS REPORTED THAT TREATING NEUROLOGIST DOES NOT BELIEVE THAT THE EVENT IS RELATED TO THE VNS THERAPY SYSTEM AND THAT THE DEATH IS BELIEVED TO BE DUE TO NATURAL CAUSES. TREATING NEUROLOGIST BELIEVES THAT THE CORONER WILL DOCUMENT THE DEATH AS SUDEP. IT WAS REPORTED THAT AN AUTOPSY IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ LYJ CYBERONICS, INC. 102 012824

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other