BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1644487-2008-00576

    MDR report key: 1810797 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00576
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 1, 2007
    Report Date
    October 8, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. ARTICLE CITATION: "EFFICACY OF VAGUS NERVE STIMULATION FOR REFRACTORY EPILEPSY: A RE-ANALYSIS USING THE ENGEL CLASSIFICATION"; WHEELER, MARCUS, ET AL. 2007.

    Description of Event or Problem · 1

    MANUFACTURER REC'D STUDY ARTICLE NOTING THAT 41.4% OF 116 PTS (48 PTS) TREATED AT TWO SPECIFIC MEDICAL CENTERS DID NOT RECEIVE EFFICACY FROM THE VNS THERAPY SYSTEM. DIAGNOSTIC RESULTS ARE NOT AVAILABLE FOR ANY OF THESE PTS' PULSE GENERATORS, THUS DEVICE MALFUNCTIONS CANNOT BE RULED OUT. THIS MEDWATCH REPRESENTS ONE PT OUT OF THAT 48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1