BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1930350 · Received November 24, 2010

    Report

    Report Number
    1644487-2010-02674
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE NURSE THAT THE PT SHOWED HIGH LEAD IMPEDANCE ON DIAGNOSTICS TEST. PT WAS LAST SEEN IN THE OFFICE ON (B)(6) 2010 AND EVERYTHING WAS NORMAL THAT TIME. PT DENIES ANY MANIPULATION OR TRAUMA THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. IT WAS INFORMED TO THE NURSE TO TURN OFF THE GENERATOR TO AVOID FURTHER COMPLICATIONS. X-RAYS WERE TAKEN AND WILL SEND TO MFR FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 11863

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR