BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 746364 · Received August 11, 2006

    Report

    Report Number
    1644487-2006-00284
    Event Type
    Death
    Date Received
    August 11, 2006
    Date of Event
    June 13, 2006
    Report Date
    July 13, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TREATING PHYSICIAN INDICATED THAT, THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY. TREATING PHYSICIAN INDICATED THAT THE CAUSE OF DEATH WAS SUDEP (SUDDEN UNEXPLAINED DEATH IN EPILEPSY). IT WAS REPORTED THAT THE PT WAS FOUND DEAD IN BED IN THE MORNING WITH NO EVIDENCE OF SEIZURE. TREATING PHYSICIAN INDICATED THAT THE PATIENT EXPERIENCED A >50% REDUCTION IN SEIZURE ACTIVITY WITH THE VNS THERAPY AND WAS RECEIVING THERAPY AT THE TIME OF DEATH. SYSTEM DIAGNOSTICS TESTING PERFORMED AT OFFICE VISIT APPROX THREE MONTHS PRIOR TO DEATH WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. TREATING PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH. IT WAS REPORTED THAT THE NCP SYSTEM WAS NOT EXPLANTED AND WILL THEREFORE NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ LYJ CYBERONICS, INC. 101 29648C

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death LAMOTRIGINE| MEDICATIONS AT TIME OF DEATH INCLUDE:| LEVETIRACETAM| BIPOL LEAD MODEL 300-20| IMPLANT DATE: