BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 1252393 · Received December 3, 2008

    Report

    Report Number
    1644487-2008-02869
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 7, 2008
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - DEVICE MANUFACTURING RECORDS WERE REVIEWED. RESULTS - OTHER - REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAD DEVELOPED A BULGE IN HER NECK TWO MONTHS AFTER IMPLANT SURGERY AND INDICATED THAT PUS HAD DISCHARGED FROM THE SITE. THE PATIENT'S IMPLANTING SURGEON RELATED THE EVENT TO AN INFECTION AND INDICATED THAT THE EVENT WOULD BE ADDRESSED WITH MEDICATION AND THAT NO ADDITIONAL SURGICAL INTERVENTIONS WOULD BE TAKEN. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 303 LYJ CYBERONICS INC. 303-20 1686

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention