BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS THERAPY CABLE

    MDR report key: 435862 · Received December 28, 2002

    Report

    Report Number
    1644487-2002-00550
    Event Type
    Injury
    Date Received
    December 28, 2002
    Date of Event
    November 1, 2002
    Report Date
    December 4, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT'S NCP SYSTEM WAS EXPLANTED DUE TO INFECTION. THE INFECTION WAS PRESENT AT BOTH THE PULSE GENERATOR/POCKET AND BIPOLAR LEAD/CERVICAL AREAS AND WAS TREATED WITH ANTIBIOTICS AND EXPLANT OF THE NCP SYSTEM. PHYSICIAN INDICATED THAT THE PATIENT'S INFECTION WAS A DIRECT RESULT OF THE IMPLANT PROCEDURE AND THAT THE PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY CABLE PULSE GENERATOR LYJ CYBERONICS, INC. 102 6593

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Hospitalization| R LOT NO. 5986.| 05/31/2004, DATE OF MFG. 05/09/2002, STERILIZATION| MODEL 302-20 VNS THERAPY LEAD, EXPIR DATE