BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 390954 · Received April 26, 2002

    Report

    Report Number
    1644487-2002-00176
    Event Type
    Other
    Date Received
    April 26, 2002
    Date of Event
    March 23, 2002
    Report Date
    March 29, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A DISCUSSION WITH AN FDA/ODE STAFF MEMBER CONCERNING A REGULATORY SUBMISSION, A NEWSPAPER ARTICLE WAS MENTIONED THAT REPORTED AN EVENT INVOLVING A VNS PT. A VNS PT HAD A SEIZURE WHILE DRIVING BUT CONTINUED TO DRIVE AFTER SELF-ADMINISTERING TREATMENT (ACTIVATING STIMULATOR WITH MAGNET). SHORTLY AFTER THE SEIZURE, THE PT CRASHED THEIR VEHICLE INTO ANOTHER VEHICLE, KILLING THE FOUR OCCUPANTS OF THE OTHER VEHICLE. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE. THERE IS NO ALLEGATION OF DEVICE DEFICIENCY. THERE IS NO INDICATION THAT THE VNS THERAPY CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2837

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other DATE OF MFG 04/25/2001, STERILIZATION LOT # 2836.| MODEL 300-20 NCP BIPOLAR LEAD EXPIR DATE 4/30/2003