BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCP BIPOLAR LEAD

    MDR report key: 643485 · Received October 28, 2005

    Report

    Report Number
    1644487-2005-00728
    Event Type
    Malfunction
    Date Received
    October 28, 2005
    Report Date
    September 30, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PATIENT'S INFECTION RESOLVED AND A NEW VNS SYSTEM WAS IMPLANTED.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS UNDERWENT NCP SYSTEM REPLACEMENT SURGERY DUE TO LEAD FRACTURE. THE PATIENT HAD NOT EXPERIENCED ANY RECENT INJURY OR TRAUMA THAT THEY MAY HAVE DAMAGED THE NCP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP BIPOLAR LEAD BIPOLAR LEAD LYJ CYBERONICS, INC. 300-20 32266C

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR