BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 487939 · Received October 9, 2003

    Report

    Report Number
    1644487-2003-00581
    Event Type
    Death
    Date Received
    October 9, 2003
    Date of Event
    August 30, 2003
    Report Date
    September 12, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF CONTACTING THE PT'S NEUROLOGIST TO NOTIFY HIM THAT THE PT'S DEVICE MAY BE NEARING END OF SERVICE, IT WAS DISCOVERED THAT THE PT HAD PASSED AWAY. CAUSE OF DEATH IS UNKNOWN AT THIS ITME. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AUTOPSY RESULTS ARE PENDING. FURTHER FOLLOW-UP REVEALED THAT THE PT WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH, BUT THAT THERE WAS NO CHANGE IN THE PT'S SEIZURES WITH THE VNS THERAPY. THE PT WAS SEEN BY NEUROLOGIST APPROX 3 WEEKS PRIOR TO DEATH AT WHICH TIME DEVICE DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS (INDICATING PROPER DEVICE FUNCTION) AND ELECTIVE REPLACEMENT INDICATOR WAS "NO" (INDICATING THAT THE GENERATOR HAD NOT REACHED END OF SERVICE). AT LAST OFFICE VISIT, THE PT REPORTED SOME DIFFICULTY SWALLOWING THAT WAS POSSIBLY MORE THAN THE PRE-VNS BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 29278C

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death LOT NO. 27068C.| REGRANEX 0.01% GEL (APPLY QD).| ANTI-EPILEPTIC MEDICATIONS AT TIME OF DEATH:| MODEL 300-20 NCP BIPOLAR LEAD. EXPIR DATE| 08/31/2001, DATE OF MFG 08/20/1999, STERILIZATION| TOPOMAX (225MG/DAY),| PHENOBARBITAL (60MG/AM, 30MG/PM),| LAMICTAL (400MG/DAY),