BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1800102 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01853
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE SURGEON THAT THE PT WAS REFERRED TO HIM FOR FULL REVISION DUE TO HIGH LEAD IMPEDANCE. IT WAS STATED BY THE FAMILY THAT THE DEVICE HAS BEEN WORKING REALLY WELL UNTIL RECENTLY. DEVICE WAS LAST CHECKED IN (B)(6)2009 AND EVERYTHING WAS OKAY. PT'S GENERATOR WAS PLACED IN THE SCAPULAR REGION AND SURGEON FELT THAT THIS MAY HAVE CONTRIBUTED TO A BREAK IN THE LEAD. PT IS ALSO HAVING AN INCREASE IN SEIZURES AND PHYSICIAN FEELS THAT IT COULD BE RELATED TO THE NON FUNCTIONING VNS. PT HAD HER DEVICE REPLACED. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED PRODUCTS FOR ANALYSIS HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC. 302-20 7083

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention