BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1052251 · Received May 23, 2008

    Report

    Report Number
    1644487-2008-01218
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 25, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT PRESENTED WITH HIGH LEAD IMPEDANCE. THE PT'S FAMILY STATED THAT IN PAST FEW WEEKS THE PT'S SEIZURES HAVE INCREASED, BUT BELOW PRE-VNS BASELINE. THE PT HAS NOT EXPERIENCED ANY TRAUMA OR MANIPULATION OF THE DEVICE X-RAYS WERE REVIEWED BY THE MFR. NO OBVIOUS GROSS LEAD DISCONTINUITIES WERE OBSERVED. THE PT UNDERWENT VNS THERAPY SYSTEM REVISION SURGERY. THE EXPLANTED PRODUCTS HAVE BEEN RETURNED TO THE MFR AND ARE PENDING PRODUCT ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 6575

    Patients

    Seq Age Sex Outcome Treatment
    1