BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1913346 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02547
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT'S VNS INDICATED HIGH IMPEDANCE DURING A DIAGNOSTICS TEST PERFORMED AT A ROUTINE OFFICE VISIT. IT WAS RECOMMENDED TO THE REPORTER THAT THE PATIENT'S VNS BE DISABLED TO PREVENT FURTHER INJURY AND TAKE X-RAYS TO ATTEMPT TO VISUALIZE A LEAD BREAK. THE REPORTER NOTED THAT THE PATIENT STATED SHE COULD NOT FEEL STIMULATION ANYMORE. NO TRAUMA OR MANIPULATION HAS BEEN REPORTED. FURTHER ATTEMPTS FOR INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1994

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR