BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1993841 · Received February 11, 2011

    Report

    Report Number
    1644487-2011-00254
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    August 1, 2010
    Report Date
    January 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED. 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 THE PATIENT'S NECK WOUND FROM VNS IMPLANT HAD BEEN EXPERIENCING DRAINAGE FOR APPROX FOUR MONTHS AND THE WOUND WAS GETTING LARGER. IT WAS INDICATED THAT THERE WAS GRANULATION TISSUE AT THE MEDIAL ASPECT OF THE WOUND THAT WAS CAUTERIZED USING SILVER NITRATE. A PORTION OF THE LEAD WAS VISIBLE WITHIN THE GRANULATION. THE PHYSICIAN ALSO PRESCRIBED BACITRACIN TO TREAT THE WOUND DEHISCENCE. IT WAS LATER FOUND THAT THE WOUND WAS LIKELY A STITCH ABSCESS. THIS WAS REMOVED AND THE WOUND WAS CLEANED. THE VNS LEAD WAS NOT REMOVED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200487

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention