BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1191916 · Received October 1, 2008

    Report

    Report Number
    1644487-2008-02383
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 2, 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

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

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS PT UNDERWENT VNS LEAD REPLACEMENT SURGERY DUE TO A LEAD DISCONTINUITY. ATTEMPTS TO THE REPORTER FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS FOR LEAD PRODUCT INFO FROM THE IMPLANTING HOSP HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTING HOSP DISCARDED THE LEAD BY ACCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR