BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1872112 · Received October 14, 2010

    Report

    Report Number
    1644487-2010-02303
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    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 INITIALLY REPORTED BY THE PHYSICIAN THAT THE PATIENT SHOWED HIGH LEAD IMPEDANCE AND IS BEING REFERRED FOR A FULL REVISION SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009405

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR