BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 2180950 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01666
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD ANOTHER SURGERY DUE TO THE LEAD EXTRUSION. THE SURGEON OPENED THE INCISION SITE AND POSITIONED THE LEAD SO THAT IT WAS NO LONGER EXTRUDING FROM THE NECK. THE SURGEON WILL EXPLANT THE PATIENT IF THIS OCCURS AGAIN. THE SURGEON STILL BELIEVES THIS IS DUE TO THE PATIENT'S HELMET RUBBING AGAINST THE NECK. THERE WAS NO INFECTION PRESENT AND DIAGNOSTICS BEFORE AND AFTER THE PROCEDURE WITH WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT INCISION ON HIS NECK HAD OPENED DUE TO HIS HELMET STRAP RUBBING ON IT AND THE LEAD WAS VISIBLE THROUGH THE OPENING. THE PT HAD SURGERY TO CLOSE THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 303 LYJ CYBERONICS, INC. 303-20 200304

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention