BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAGAL NERVE STIMULATOR/CYBERONICS

    MDR report key: 386269 · Received March 26, 2002

    Report

    Report Number
    MW1024558
    Event Type
    Other
    Date Received
    March 26, 2002
    Date of Event
    February 23, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD 2 GRAND MAL SEIZURES THAT WERE UNLIKE THEIR NORMAL, LASTING >7 MINS. DEVICE WAS NOT WORKING. CYBERONICS CLAIMED 24/7 CLINICAL AND TECHNICAL SUPPORT UPON IMPLANTATION AND NUMEROUS ATTEMPTS BY 3 PEOPLE INCLUDING ER FOR >4HRS AND NO ONE RETURNED CALLS AND THOSE THAT THEY WERE ABLE TO SPEAK TO (NOT VOICE MAIL) KNEW NOTHING OF PRODUCT. SUSPECT THAT DEVICE MALFUNCTIONED AND CAUSED THESE SEIZURES. CYBERONICS DID NOT STAND BY CONTRACT FOR 24/7 SUPPORT AND WAS NOT AVAILABLE TO TEST DEVICE. THEY (CYBERONICS) ARE THE ONLY ONE THAT HAS COMPUTER TO INTERFACE WITH DEVICE. THESE SEIZURES WERE POTENTIALLY LIFE THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGAL NERVE STIMULATOR/CYBERONICS FOR SEIZURE CONTROL/IMPLANTED LYJ CYBERONICS, INC. REF#10-0005-0000 BATCH 56998

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other