BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY PULSE

    MDR report key: 499589 · Received December 8, 2003

    Report

    Report Number
    1644487-2003-00726
    Event Type
    Injury
    Date Received
    December 8, 2003
    Date of Event
    February 28, 2003
    Report Date
    May 27, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PATIENT HAS REQUESTED THAT THE DEVICE BE EXPLANTED. THE PATIENT HAS REPORTEDLY EXPERIENCED SHORTNESS OF BREATH SINCE IMPLANT AND HAS NOT BENEFITED FROM THE VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 7570

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R DATE OF MFG 05/06/2002, STERILIZATION LOT NO. 5986| MODEL 302-20 VNS THERAPY LEAD, EXPIR: 04/30/2004,