BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 418005 · Received September 18, 2002

    Report

    Report Number
    1644487-2002-00406
    Event Type
    Death
    Date Received
    September 18, 2002
    Date of Event
    July 9, 2002
    Report Date
    August 22, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT HAD PASSED AWAY. THE EXACT CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. THE PATIENT WAS FOUND DEAD ON THE FLOOR, FACE-DOWN WITH TONGUE BITTEN. THE NCP SYSTEM WAS NOT EXPLANTED AND NO AUTOPSY WAS PERFORMED. PATIENT WAS LAST SEEN BY PHYSICIAN ON 06/20/2002 AND WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH. PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2836

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death LOT NO. 2450. PATIENT'S AEDS INCLUDED:| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE| 03/31/2003, DATE OF MFG 03/15/2001, STERILIZATION| LORAZEPAM (DOSAGES UNKNOWN).| CARBAMAZEPINE, VALPROATE/VALPORIC ACID, AND