BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 554423 · Received November 15, 2004

    Report

    Report Number
    1644487-2004-01000
    Event Type
    Death
    Date Received
    November 15, 2004
    Date of Event
    October 17, 2004
    Report Date
    October 18, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. IT WAS REPORTED THAT FAMILY MEMBER FOUND THE PT UNRESPONSIVE AT HOME. THE PT HAD BEEN LYING ON THE COUCH WATCHING TELEVISION AND PRESUMABLY FELL ASLEEP. FAMILY MEMBER, WHO WAS IN THE NEXT ROOM, DID NOT HEAR ANYTHING. FAMILY MEMBER FOUND THAT PT HAD ROLLED OFF THE COUCH AND THEIR HEAD WAS IN THE TRASH BASKET. IT HAD NO PLASTIC LINEAR BUT SOME TISSUES, WHICH WERE WET WITH SALIVA. ALL ATTEMPTS TO RESUSCITATE PT FAILED AND PT WAS PRONOUNCED DEAD IN THE HOSPITAL EMERGENCY ROOM. COUNTY CORONER INDICATED THAT HE DID NOT FIND ANYTHING UNUSUAL ON THE GROSS EXAMINATION OF THE ORGANS AND THAT THE DEATH WAS LIKLEY DUE TO SUDEP (SUDDEN UNEXPLANTED DEATH IN EPILEPSY). THE PT HAD BEEN AVERAGING 1 GRAND MAL SEIZURE PER WEEK AND THERE HAD BEEN NO CHANGE IN SEIZURE FREQUENCY, NO MISSED MEDICATION OR NO ILLNESS PRIOR TO DEATH. IT WAS REPORTED THAT THE PT EXPERIENCED A >50% REDUCTION IN SEIZURES WITH THE VNS THERAPY AND THAT PT WAS RECEIVING THERAPY AT THE TIME OF DEATH. DEVICE DIAGNOSTIC TESTING PERFORMED THREE MONTHS PRIOR TO DEATH WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. DEVICE END OF SERVICE IS NOT LIKELY BASED ON KNOWN DEVICE SETTINGS AND DEVICE DIAGNOSTIC TEST RESULTS. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. TREATING NEUROLOGIST INDICATED THAT THE RELATIONSHIP BETWEEN THE NCP SYSTEM AND THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 7629C

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Death MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 5/31/00,| MEDICATIONS AT TIME OF EVENT INCLUDE: TRILEPTAL.| DATE OF MFG 5/4/98, STERILIZATION LOT NO. 10752C.