BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1200118 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05288
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVAL HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A LEVEEN NEEDLE ELECTRODE WAS USED IN AN RF ABLATION PROCEDURE PERFORMED ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, THE RF GENERATOR "SUDDEN SWITCH OFF DURING THE PROCEDURE WITHOUT ABLATION OF THE LESION ALTHOUGH THE POWER MAXIMUM." IT WAS FURTHER REPORTED THAT THE GROUND PAD, THE RF GENERATOR WERE REPLACED. ULTIMATELY, THE NEEDLE ELECTRODE WAS REPLACED WITH ANOTHER LEVEEN NEEDLE ELECTRODE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'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 M001262130 11178424

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR