BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1022741 · Received March 27, 2008

    Report

    Report Number
    1644487-2008-00778
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 LEAD REVISION SURGERY OCCURRED DUE TO A LEAD DISCONTINUITY. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO 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

    Patients

    Seq Age Sex Outcome Treatment
    1