BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS NEUROCYBERNETIC PROSTHESIS

    MDR report key: 318131 · Received February 23, 2001

    Report

    Report Number
    1644487-2001-00118
    Event Type
    Injury
    Date Received
    February 23, 2001
    Date of Event
    May 16, 2000
    Report Date
    October 6, 2000
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    DESCRIBE EVENT OR PROBLEM: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7554 CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR LYJ CYBERONICS, INC. 101 33539C

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| O| R MODEL 300-20 BIPOLAR LEAD,| STERILIZATION LOT# 32572C.| EXPIRE 12/2001, DATE OF MFG 12/1999,