BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1644487-2008-00518

    MDR report key: 1810801 · Received February 29, 2008

    Report

    Report Number
    1644487-2008-00518
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Date of Event
    January 1, 2007
    Report Date
    September 6, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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: "VAGUS NERVE STIMULATION FOR INTRACTABLE EPILEPSY: OUTCOME IN TWO SERIES COMBINING 90 PATIENTS"; SAKAS, D.E., ET AL; SPRINGER-VERLAG 2007.

    Description of Event or Problem · 1

    ARTICLE WAS REC'D THAT DESCRIBED THE FOLLOWING INCIDENT REGARDING A STUDY PT THAT WAS IMPLANTED WITH THE VNS THERAPY SYSTEM: PT DID NOT EXPERIENCE ANY EFFICACY AS A RESULT OF BEING IMPLANTED WITH THE VNS THERAPY SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1