BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1781170 · Received July 29, 2010

    Report

    Report Number
    1644487-2010-01754
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 PT SHOWED HIGH LEAD IMPEDANCE WITH DIAGNOSTICS TEST. PT WAS PROGRAMMED OFF AND WAS REFERRED TO SURGEON FOR A POSSIBLE FULL REVISION SURGERY. PHYSICIAN STATED THAT THE PT IS DOING GREAT WITH VNS AND WILL NEED VNS AGAIN. PT COULD NOT FEEL STIMULATION AND NO MANIPULATION OR TRAUMA WAS REPORTED THAT COULD HAVE CONTRIBUTED TO THE EVENT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1330

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male