BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 2050084 · Received March 31, 2011

    Report

    Report Number
    1644487-2011-00678
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 4, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS PROGRAMMING OFFICE IN (B)(4) REPORTED TO OUR VNS CONSULTANT THAT THEY HAD A PT WHO CAME INTO CLINIC AND PRESENTED WITH HIGH LEAD IMPEDANCE. THE EVENT WAS NOTED ON (B)(6) 2011, THE LEAD IMPEDANCE WAS GREATER THAN 10,000 OHMS. THE PT HAD THEIR VNS PROGRAMMED OFF. THERE WAS NO REPORTED BLUNT TRAUMA PRIOR TO THE EVENT. THE CHILD IS OF ADULT SIZE AND IS KNOWN FOR HAVING GENERALIZED TONIC CLONIC SEIZURES. SINCE THEIR DEVICE WAS PROGRAMMED OFF, THEIR SEIZURES HAVE INCREASED BUT THE SEIZURE TYPE HAS NOT CHANGED. PREVIOUS DIAGNOSTICS WERE CHECKED ON THE PT'S VNS ON (B)(6) 2010, AND ALL WERE REPORTED TO BE WITHIN NORMAL LIMITS AND THE PT WAS NOT HAVING INCREASED SEIZURES. THE PT IS ON A LIST FOR SURGERY BUT NO DATE HAS BEEN SET AT THIS TIME. X-RAYS WERE RECEIVED FOR REVIEW. NO OBVIOUS LEAD BREAKS WERE NOTED. A PORTION OF THE LEAD WAS BEHIND THE GENERATOR; THEREFORE, COULD NOT BE ASSESSED. A SUSPECT AREA WAS NOTED NEAR THE GENERATOR THAT CANNOT BE RULED OUT AS THE CAUSE OF THEIR HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 21867C

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR