BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 529405 · Received June 10, 2004

    Report

    Report Number
    1644487-2004-00353
    Event Type
    Injury
    Date Received
    June 10, 2004
    Date of Event
    August 31, 2001
    Report Date
    May 6, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S DEVICE WAS PROGRAMMED TO OFF AS IT WAS BELIEVED THAT THE VNS THERAPY WAS EXACERBATING THE PT'S PRE-EXISTING SLEEP APNEA. BOTH THE PT AND THEIR CURRENT NEUROLOGIST BELIEVE THAT THE NCP SYSTEM SHOULD NOT HAVE BEEN IMPLANTED AND IS LIKELY PRODUCING NO BENEFIT. TREATING NEUROLOGIST INDICATED THAT THE NCP SYSTEM WOULD BE EXPLANTED AT A LATER DATE IF THE PT CONTINUED TO DO WELL WITH THE DEVICE PROGRAMMED TO OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 3535

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R 4. KEPPRA.| INCLUDE: 1. TEGRETOL,| 06/30/2003, DATE OF MFG 06/18/2001, STERILIZATION| MODEL 300-20 NCP BIOPLAR LEAD, EXPIR DATE| LOT NO. 3359. MEDICATIONS AT TIME OF EVENT| 3. DILANTIN (DISCONTINUED),| 2. DEPAKOTE (DISCONTINUED),