BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1080707 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01682
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT DIED IN HIS SLEEP. FOLLOW UP WITH THE TREATING PHYSICIAN'S OFFICE REVEALED THAT THE CAUSE OF DEATH IS UNK AND IT IS UNK IF THE DEATH WAS RELATED TO VNS THERAPY, BUT IT IS BELIEVED THAT THE PT HAD A SEIZURE WHILE SLEEPING AND SUFFOCATED AS A RESULT.

    Description of Event or Problem · 1

    CAUSE OF DEATH INFORMATION OBTAINED FROM THE (B)(6) WAS REVIEWED BY THE MANUFACTURER WHICH INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2008 AND THE PATIENT'S CAUSE OF DEATH WAS: CHILDHOOD AUTISM; OTHER AND UNSPECIFIED CONVULSIONS. A SUDEP (SUDDEN UNEXPECTED DEATH IN EPILEPSY) EVALUATION WAS PERFORMED WHICH DETERMINED THAT THE DEATH MET CRITERIA FOR CLASSIFICATION OF PROBABLE SUDEP. THERE IS NO ALLEGATION OR OTHER INFORMATION INDICATING THAT THE DEATH IS RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200611

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death