BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 538748 · Received August 13, 2004

    Report

    Report Number
    1644487-2004-00675
    Event Type
    Death
    Date Received
    August 13, 2004
    Date of Event
    June 17, 2004
    Report Date
    July 15, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE PT EXPIRED DURING THE NIGHT DUE TO "RESPIRATORY TRACT CLOSING" WHILE SLEEPING. THE PHYSICIAN INDICATED THAT THE PT'S FAMILY MEMBER REPORTED THAT THE BREATH HOLDING DURING SEIZURES SEEMED TO BE THE CAUSE OF DEATH. DUE TO INSURANCE ISSUES, THE PT HAD NOT GONE TO THE NEUROLOGIST FOR TWO YEARS. THE PT DID NOT RECEIVE EFFICACY FROM THE VAGUS NERVE THERAPY. THE TREATING NEUROLOGIST INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE PT'S DEATH. AN AUTOPSY WAS NOT PERFORMED. THE NCP SYSTEM WAS NOT EXPLANTED. THERE IS NO EVIDENCE THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE PT'S DEATH. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 4084

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death EXPIR DATE 09/30/2003, DATE OF MFG 09/05/2001,| LAST KNOWN MEDS: CARBAMAZEPINE| MODEL 300-20 NCP BIPOLAR LEAD,| LAST KNOWN MEDS: VALPROATE/VALPROIC ACID,| STERILIZATION LOT NO. 4105.| LAST KNOWN MEDS: CLONAZEPAM