BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 543837 · Received September 17, 2004

    Report

    Report Number
    1644487-2004-00727
    Event Type
    Death
    Date Received
    September 17, 2004
    Date of Event
    August 14, 2004
    Report Date
    August 20, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT PASSED AWAY. THE CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. FURTHER FOLLOW-UP WITH THE PT'S TREATING NEUROLOGIST REVEALED THAT THE PT WAS FOUND DEAD AT HOME, AN AUTOPSY WAS NOT PERFORMED, AND THE PULSE GENERATOR WAS NOT REMOVED PRIOR TO BURIAL. THE NEUROLOGIST ALSO NOTED THAT THE NCP SYSTEM WAS NOT RELATED TO THE PT'S DEATH. DIAGNOSTIC TESTING WAS PERFORMED APPROXIMATELY TWO MONTHS PRIOR TO THE PT'S DEATH. TESTING CONCLUDED THAT THE NCP SYSTEM WAS PROPERLY FUNCTIONING AT THAT TIME. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. THERE IS NO EVIDENCE AT THIS TIME 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 6350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death MODEL 300-30 NCP BIPOLAR LEAD, EXPIR DATE| 01/31/2002, DATE OF MFG 12/22/1999, STERILIZATION| LOT NO. 32937C, IMPLANTED 2000.