BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1260038 · Received December 10, 2008

    Report

    Report Number
    1644487-2008-02976
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WANTS HER DEVICE REMOVED BECAUSE THE LEADS ARE PROTRUDING AT THE NECK. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention