BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 412808 · Received August 23, 2002

    Report

    Report Number
    1644487-2002-00376
    Event Type
    Death
    Date Received
    August 23, 2002
    Date of Event
    June 7, 2001
    Report Date
    July 24, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF CONTACTING THE PT TO NOTIFY THEM THAT THEIR DEVICE MAY BE NEARING END OF SERVICE, IT WAS DISCOVERED THAT THE PT HAD PASSED AWAY DUE TO A RARE GENETIC SYNDROME (AICARDI SYNDROME). THE PT'S NCP SYSTEM WAS NOT EXPLANTED. VNS THERAPY REPORTEDLY WORKED WELL FOR THE PT (>25% REDUCTION IN SEIZURES). PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 21619C

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death EXPIRE DATE 08/31/2000, DATE OF MFG 08/21/1998,| STERILIZATION LOT NO. 14908C.| (DOSAGES UNKNOWN).| PHENOBARBITOL, PRIMIDONE, KEPPRA, GABITRIL| ANTI-EPILEPTIC MEDICATIONS INCLUDED:| MODEL 300-20 NCP BIPOLAR LEAD,