BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1051115 · Received May 21, 2008

    Report

    Report Number
    1644487-2008-01193
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS WAS SCHEDULED FOR REVISION SURGERY TO HAVE THE LEAD AND GENERATOR REPLACED DUE TO A SUDDEN ONSET OF PAINFUL STIMULATION IN THE THROAT, TIGHTENING IN THE THROAT DURING STIMULATION, PROTRUSION OF TWO TIE DOWNS IN THE NECK, AND AN INCREASE IN SEIZURE ACTIVITY. THE EVENTS WERE PRECEDED BY A CAR ACCIDENT IN WHICH THE SEAT BELT WAS ACROSS THE LEFT NECK. A DIAGNOSTIC TEST WAS PERFORMED PRE-OPERATIVELY AND YIELDED NORMAL RESULTS, INDICATING NORMAL DEVICE FUNCTION. NO X-RAYS WERE TAKEN TO RULE OUT A GROSS LEAD BREAK. THE GENERATOR WAS REPLACED PROPHYLACTICALLY, AND THE LEAD AND TIE DOWNS WERE REPLACED AS WELL. THE EXPLANTED PORTION OF THE LEAD AND THE GENERATOR HAS BEEN RETURNED TO MFR AND ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 8457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention