BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 530608 · Received June 18, 2004

    Report

    Report Number
    1644487-2004-00529
    Event Type
    Death
    Date Received
    June 18, 2004
    Date of Event
    August 2, 2003
    Report Date
    September 19, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT AN AUTOPSY WAS NOT PERFORMED. THE DEATH CERTIFICATE LISTED THE IMMEDIATE CAUSE OF DEATH AS UNKNOWN NATURAL CAUSES, DUE TO (OR AS A CONSEQUENCE OF) ALZHEIMERS, DUE TO (OR AS A CONSEQUENCE OF) DIABETES. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH, BUT NOT RESULTING IN THE UNDERLYING CAUSE WERE LISTED AS PULMONARY EDEMA, SEIZURE. THE MANNER OF DEATH WAS LISTED AS NATURAL.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE PT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. THERE IS NO EVIDENCE THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 3673

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DATE OF MFG 08/02/2001, STERILIZATION LOT NO. 3791| MODEL 300-20 BIPOLAR LEAD, EXPIR DATE 08/31/2003,