BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1235780 · Received November 18, 2008

    Report

    Report Number
    3005099803-2008-06537
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN RETURNED. THE DEVICE EVAL HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THE EVENT WAS REPORTED TO HAVE OCCURRED IN 2008; THE ACTUAL DATE IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A RF ABLATION PROCEDURE ON THE PT'S LIVER. ACCORDING TO THE COMPLAINANT, AFTER 15 MINUTES, "NOTHING HAPPENED, NO HEAT, NO GAZ." IT WAS FURTHER REPORTED THAT THE PHYSICIAN REMOVED AND REPLACED THE DEVICE WITH ANOTHER LEVEEN NEEDLE ELECTRODE DEVICE. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE GEI BOSTON SCIENTIFIC CORPORATION M001262050 11899637

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK