BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 410659 · Received August 16, 2002

    Report

    Report Number
    1644487-2002-00360
    Event Type
    Death
    Date Received
    August 16, 2002
    Date of Event
    January 29, 2001
    Report Date
    July 17, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCESS OF NOTIFYING THE PT THAT THEIR DEVICE MAY BE NEARING END OF SERVICE, IT WAS DISCOVERED THAT THE PT HAD PASSED AWAY. THE PT HAD REPORTEDLY DIED FROM ASPHYXIA DUE TO DROWNING FROM SEIZURES. THE PT'S NCP SYSTEM WAS NOT EXPLANTED. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 19797C

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death DATE OF MFG 11/06/1998, STERILIZATION| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE| LOT NO. 18102C.