BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1840049 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02094
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 17, 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

    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 A PT REPORTED NOT BEING ABLE TO FEEL STIMULATION (NORMAL OR MAGNET MODE) FOR THE PAST THREE MONTHS. DIAGNOSTICS PERFORMED RESULTED IN HIGH LEAD IMPEDANCE. THE PT DENIED ANY TRAUMA TO THE SITE. X-RAYS WERE TAKEN AND REVIEWED BY THE PHYSICIAN WHO COULD NOT SEE ANY LEAD DISCONTINUITIES. THE LEAD PIN WAS FULL INSERTED. THE X-RAYS WILL NOT BE SENT TO THE MANUFACTURER FOR REVIEW. IT WAS RECOMMENDED TO THE PHYSICIAN THAT THE PT'S DEVICE BE PROGRAMMED OFF. THE PT WILL BE REFERRED FOR A SURGICAL CONSULT. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL 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 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR