BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303-20

    MDR report key: 3148350 · Received June 5, 2013

    Report

    Report Number
    1644487-2013-01691
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PATIENT PRESENTED WITH CHANGES IN SCAR TISSUE HEALING ON THE NECK ON (B)(6) 2013 FOLLOWING INITIAL VNS IMPLANT SURGERY ON (B)(6) 2013. THE PATIENT WAS ALSO VERY RESTLESS, BUT WHEN THE VNS WAS DISABLED THE PATIENT CALMED DOWN. IT WAS THOUGHT THERE MAY BE A LEAD DISLOCATION OR ¿AKZIDENTELLER STIMULATION OF VESSELS¿, BUT DEVICE DIAGNOSTICS INDICATED NORMAL FUNCTION WITH 2066 OHMS. X-RAYS MAY BE PERFORMED. THE REPORTER IS CONCERNED THAT SURGERY MAY BE NEEDED TO RECTIFY THE SITUATION. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE VNS SETTINGS WERE NOT CHANGED, AND THERE WAS NO ISSUE WITH STIMULATION. THE VNS WAS TURNED BACK ON AND PROGRAMMED TO 1 MA. NO INTERVENTIONS ARE PLANNED, AND THE PATIENT IS ¿DOING OK¿. X-RAYS WERE RECEIVED TO THE MANUFACTURER FOR REVIEW. NO GENERATOR VIEWS WERE PROVIDED. THERE WERE NO ACUTE ANGLES OR FRANK LEAD BREAKS OBSERVED IN THE AVAILABLE VIEWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248101 LEAD MODEL 303-20 LEAD LYJ CYBERONICS INC 303-20 3492

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention