BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS NEUROCYBERNETIC PROSTHESIS

    MDR report key: 318334 · Received February 23, 2001

    Report

    Report Number
    1644487-2001-00050
    Event Type
    Injury
    Date Received
    February 23, 2001
    Date of Event
    August 9, 1999
    Report Date
    August 10, 1999
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7602 CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR LYJ CYBERONICS, INC. 100 21024C

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| O| R STERILIZATION LOT# 17080C.| MODEL 300-20 BIPOLAR LEAD.| EXPIRE 10/01/2000, DATE OF MFG 10/19/1998,