BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1943924 · Received December 1, 2010

    Report

    Report Number
    1644487-2010-02697
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEM DIAGNOSTIC TESTS RESULTED IN HIGH LEAD IMPEDANCE DURING AN OFFICE VISIT. THE REPORTER STATED THAT THERE IS NO KNOWN TRAUMA THAT MAY HAVE CAUSED THE HIGH LEAD IMPEDANCE. THE PT'S GENERATION HAS BEEN TURNED OFF AND X-RAYS WERE TAKEN. X-RAYS WERE RECEIVED AND EVALUATED BY THE MFR. REVIEW OF X-RAYS INDICATED THE GENERATOR WAS PLACED IN THE LEFT CHEST IN A NORMAL ORIENTATION. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED. THE LEAD APPEARED TO BE INTACT AT THE CONNECTOR PIN AND SOME LEAD WAS PRESENT BEHIND THE GENERATOR. THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT AT THE CONNECTOR PIN. THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODES APPEARED TO BE NORMAL. HOWEVER, A SUSPECT LEAD DISCONTINUITY WAS SEEN ON THE POSITIVE ELECTRODE IN THE NECK AREA. THE PT WILL MOST LIKELY BE REFERRED FOR REVISION SURGERY. HOWEVER, NO SURGERY HAS BEEN PLANNED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 010599

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female