BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1140635 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04167
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED NO OBVIOUS ANOMALIES. THE ELECTRODE ARRAY WAS RETRACTED AND EXTENDED WITHOUT ABNORMAL RESISTANCE; EXCESS FORCE WAS NOT NECESSARY TO ACTUATE THE ARRAY. THE REPORTED MALFUNCTION IS NOT CONFIRMED; THE CAUSE IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME LOT. THE JULY 2008 15-MONTH RF PROBES PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO REPORTED MALFUNCTIONS WHICH OCCURRED DURING THE SAME PROCEDURE. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED ON THE SAME DATE TO PERFORM AN RF ABLATION ON A PATIENT'S LUNG. ACCORDING TO THE COMPLAINANT, "FORCE WAS NEEDED TO DEPLOY AND RETRACT THE TINES INTO THE SHEATH DURING PREPARATION. THE DEVICE PRODUCED A SQUEAKY SOUND WHEN IT SCRAPED THE INNER AND OUTER SHEATH." REPORTEDLY THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. REFER TO MFR REPORT #3005099803-2008-01XXX FOR DETAILS REGARDING THE SECOND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE GEI BOSTON SCIENTIFIC CORPORATION M001262060 11472740

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK