BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1193204 · Received October 7, 2008

    Report

    Report Number
    1644487-2008-02432
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE VNS PT'S DEVICE REVEALED HIGH LEAD IMPEDANCE WHEN TESTED AT A RECENT FOLLOW UP VISIT. THIS WAS THE FIRST TIME THIS PHYSICIAN HAD SEEN THIS PT, SO THERE IS NO PREVIOUS DIAGNOSTIC TEST RESULTS AVAILABLE FROM THE REPORTER. THE PT MENTIONED THAT SHE HAD EXPERIENCED A FALL SEVERAL MONTHS PRIOR TO THIS OFFICE VISIT, HOWEVER, THIS WAS THE FIRST TIME THE DEVICE HAD BEEN CHECKED SINCE THE FALL. THE PT HAS NOTED AN INCREASE IN STARING SPELLS, NOT ABOVE PRE-VNS BASELINE. ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010275

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR