BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 404751 · Received July 12, 2002

    Report

    Report Number
    1644487-2002-00281
    Event Type
    Death
    Date Received
    July 12, 2002
    Date of Event
    June 5, 2002
    Report Date
    June 13, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT HAD PASSED AWAY. NO CAUSE OF DEATH WAS GIVEN AT THE TIME OF THE INITIAL REPORT AND NO AUTOPSY WAS PERFORMED. THE PT WAS FOUND DEAD IN BED. THE PHYSICIAN INDICATED THAT THE DEATH WAS NOT RELATED TO THE NCP SYSTEM AND THE NCP SYSTEM WAS NOT EXPLANTED. FURTHER FOLLOW-UP REVEALED THAT A DEATH CERTIFICATE WILL NOT BE MADE AVAILABLE TO THE MFR. 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. 101 3028

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death DATE OF MFG 02/2001, STERILIZATION LOT NO. 2220,| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE DATE 2/28/03| ANTI-EPILEPTIC MEDICATIONS AT TIME OF DEATH:| VLLPROATE/VALPROIC ACID, LAMOTRIGINE, FELBAMATE.