BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2050206 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00702
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS TO HAVE FULL REVISION SURGERY DUE TO TA SUSPECTED LEAD BREAK. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2011, DUE TO A "BROKEN LEAD". ATTEMPTS FOR FURTHER INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200356

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR