BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP)

    MDR report key: 273571 · Received April 14, 2000

    Report

    Report Number
    1644487-2000-00006
    Event Type
    Injury
    Date Received
    April 14, 2000
    Date of Event
    March 16, 2000
    Report Date
    March 17, 2000
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE EPILEPSY NURSE SPECIALIST REPORTED THAT FOLLOWING THE NCP IMPLANT, THE PT EXPERIENCED ASYSTOLE DURING THE INITIAL LEAD TEST. THE LEAD TEST WAS ATTEMPTED THREE TIMES; EACH TIME THE PT BECOME ASYSTOLIC. FOLLOWING SURGERY, THE PT WAS PLACED IN THE CRITICAL CARE UNIT AND PT COMPLAINTED OF "SEVERE CHEST PAIN EVERY HOUR." PT CONTINUED TO EXPERIENCE ASYSTOLE "EVERY HOUR FOR APPROX 12 SECONDS." THE FOLLOWING MORNING, THE EPILEPSY NURSE SPECIALIST DISCOVERED THAT THE GENERATOR HAD BEEN ACTIVATED IN THE OPERATING ROOM. NURSE IMMEDIATELY TURNED THE DEVICE OFF AND THE PT'S SYMPTOMS SUBSIDED. IT IS STATED IN THE NCP SYSTEM'S PHYSICIAN'S MANUAL, UNDER THE PRECAUTIONS SECTION, NOT TO PROGRAM THE NCP SYSTEM TO AN ON OR PERIODIC STIMULATION TREATMENT FOR AT LEAST 14 DAYS AFTER THE INITIAL OR REPLACEMENT IMPLANTATION. THE PHYSICIAN PLANS TO REACTIVATE THE GENERATOR "IN TWO WEEKS." FOLLOW-UP CALL FROM PHYSICIAN INDICATED THAT GENERATOR WAS ACTIVATED ON 3/30/2000 WITHOUT INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS NEUROCYBERNETIC PROSTHESIS (NCP) NEUROSTIMULATOR LYJ CYBERONICS, INC. 101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Life Threatening 300-20-15624 (BIPOLAR LEAD).