BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302-20

    MDR report key: 1890158 · Received October 22, 2010

    Report

    Report Number
    1644487-2010-02379
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A FRACTURE OF THE VNS LEAD WAS FOUND DURING SURGERY TO REPLACE THE VNS GENERATOR. REPLACEMENT OF THE VNS LEAD AND GENERATOR HAVE TAKEN PLACE AND ATTEMPTS FOR THE RETURN OF THE EXPLANTED PRODUCTS ARE IN PROGRESS. NO X-RAYS WERE TAKEN. NO DIAGNOSTICS WERE TAKEN PRIOR TO THE EXPLANT SURGERY. ATTEMPTS FOR FURTHER INFO ARE CURRENTLY IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302-20 LYJ CYBERONICS, INC. 302-20 009771

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR