BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2241014 · Received August 17, 2011

    Report

    Report Number
    1644487-2011-01895
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 REPORTED BY A COMPANY REPRESENTATIVE THAT A NURSE SUSPECTED A SHORT CIRCUIT CONDITION ON A VNS PT THAT HAD DCDC OF 0 SINCE 2006, BUT PRIOR TO THAT, DCDC WAS 2. FURTHERMORE, IT WAS THOUGHT THE PT'S SEIZURES HAD WORSENED SLIGHTLY SINCE THEN, BUT THE CHANGE IN DCDC CODE WAS NOT ASSOCIATED WITH THE POSSIBILITY OF THERAPY NOT BEING DELIVERED. THE PT HAD A NEW GENERATOR IMPLANTED AND WAS SEEN IN CLINIC DUE TO UNAWARENESS OF STIMULATION. X-RAYS WERE PERFORMED AND EXAMINED BY THE HOSPITAL AND COMPANY REPRESENTATIVE. NO STRAIN RELIEF BEND AND NO TIE DOWNS WERE VISUALIZED AND POSSIBLY THE ANCHOR TETHER WAS NOT ON THE NERVE. THE X-RAYS WERE RECEIVED BY THE MANUFACTURER AND EVALUATED. THE GENERATOR WAS VISUALIZED IN THE LEFT UPPER ABDOMEN, WITH ITS FRONT PART FACING THE FRONT SIDE OF THE ABDOMEN. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PINS APPEARED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE STATE OF THE LEAD WIRES AT THE CONNECTOR PIN COULD NOT BE ASSESSED DUE TO HIGH DENSITY AREAS IN THE X-RAYS. THE NEGATIVE ELECTRODE APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. THE POSITIVE ELECTRODE APPEARED TO BE PARTIALLY DETACHED FROM THE NERVE. THE LEAD COULD NOT BE FULLY ASSESSED BECAUSE OF HIGH DENSITY AREAS IN THE X-RAYS THAT CONCEALED PORTIONS OF THE LEAD. NO ACUTE ANGLES OR LEAD BREAKS WERE OBSERVED IN THE ASSESSED PORTIONS OF THE LEAD. REVIEW OF PROGRAMMING HISTORY WITH THE PT'S LAST GENERATOR INDICATED THAT SYSTEM DIAGNOSTICS DC DC HAD ALWAYS BEEN AT 0 WHILE NORMAL DIAGNOSTICS WAS INDICATIVE OF 2. PROGRAMMING HISTORY WAS NOT AVAILABLE FOR THE RECENTLY IMPLANTED GENERATOR. THE PT WAS REFERRED FOR LEAD REVISION SURGERY AND POSSIBLE GENERATOR REPLACEMENT SURGERY DUE TO LEAD COMPATIBILITY. NO TRAUMA WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT. FURTHERMORE, INFORMATION FROM THE AREA REPRESENTATIVE INDICATED THAT NO INTERVENTIONS HAVE BEEN PLANNED EVEN THROUGH REPLACEMENT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention