BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 2181240 · Received July 8, 2011

    Report

    Report Number
    1644487-2011-01541
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, FLUID WAS SEEN IN THE LEAD TUBING. THE LEAD WAS RETURNED TO THE MFR, BUT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304 LYJ CYBERONICS, INC. 304-20 2831

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male