BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 412627 · Received August 23, 2002

    Report

    Report Number
    1644487-2002-00393
    Event Type
    Death
    Date Received
    August 23, 2002
    Date of Event
    July 20, 2002
    Report Date
    July 24, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. CERTIFICATE OF DEATH LISTS RESPIRATORY ARREST AS THE IMMEDIATE CAUSE OF DEATH, DUE TO OR AS A CONSEQUENCE OF MITOCHONDRIAL DISORDER OF OXIDATIVE PHOSPHORYLATION, DUE TO OR AS A RESULT OF EPILEPSY. NO AUTOPSY WAS PERFORMED. PHYSICIAN INDICATED THAT THE PT DIED OF RESPIRATORY ARREST DURING THE NIGHT AND THERE WAS NO SEIZURE ASSOCIATED. PHYSICIAN INDICATED THAT THE NCP SYSTEM WAS NOT RELATED TO THE CAUSE OF DEATH. THE PT REPORTEDLY EXPERIENCED A >50% REDUCTION IN SEIZURES WITH THE VNS THERAPY. RETURN OF EXPLANTED PRODUCT FOR ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2450

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Death MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE5/31/2003| DATE OF MFG 05/2001, STERILIZATION LOT NO. 3151.| LORAZEPAM, ZONEGRAN (DOSAGES UNKNOWN).| ANTI-EPILEPTIC MEDICATIONS INCLUDED: LAMOTRIGINE,