BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2102239 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01138
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. IN ADDITION, SIGNIFICANT PT DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT HAD VNS LEAD REPLACEMENT SURGERY DUE TO A LEAD FRACTURE. DURING THE SURGERY, THE LEAD WAS NOTED TO BE TWISTED AND LOOPED TIGHTLY IN MULTIPLE LOCATIONS DUE TO THE PT MANIPULATING THE GENERATOR IN THE POCKET. NO X-RAYS WERE PERFORMED. ALL ATTEMPTS FOR RETURN OF THE EXPLANTED LEAD FOR PRODUCT ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 201288

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR