BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 1230883 · Received November 6, 2008

    Report

    Report Number
    1644487-2008-02679
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT A VNS PT'S LEAD MAY HAVE FRACTURED AND ADDED THAT THE PT HAS HAD "GOOD EFFECT OF HIS VNS BEFORE THIS PROBLEMS OCCURRED," INDICATING THAT AN INCREASE IN SEIZURES MAY HAVE OCCURRED. X-RAYS OF THE PT'S DEVICE WERE REVIEWED BY THE MANUFACTURER AND CONFIRMED THE PRESENCE OF A LEAD BREAK. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention