BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS INC

    MDR report key: 433816 · Received December 16, 2002

    Report

    Report Number
    MW1027008
    Event Type
    Injury
    Date Received
    December 16, 2002
    Date of Event
    July 2, 2002
    Report Date
    December 16, 2002
    Manufacturer
    *
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    SEVERE URINE RETENTION CAUSING SEVERAL SEVERE KIDNEY INFECTIONS AND UTI INFECTIONS SINCE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS INC VAGUS NERVE STIMULATOR LYJ * 101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Life Threatening