BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II

    MDR report key: 924921 · Received October 10, 2007

    Report

    Report Number
    2953184-2007-00021
    Event Type
    Injury
    Date Received
    October 10, 2007
    Report Date
    September 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC DP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN ESTABLISHED THAT CONDITIONS THAT COULD LEAD TO AN UNINTENDED, RF INDUCED ARRYTHMIA WERE PRESENT DURING THE PROCEDURE. THIS MAY BE ATTRIBUTED TO AN IMPROPER EQUIPMENT COMBINATION FOR PACING WHILE ABLATING, AS IDENTIFIED IN A PREVIOUS BOSTON SCIENTIFIC STUDY. THE STUDY FOUND THAT CERTAIN COMBINATIONS OF STIMULATORS AND RECORDING SYSTEMS ARE SUSPECTABLE TO THE CREATION OF DC VOLTAGES ACROSS A PACING-ROUTED PAIR OF ELECTRODES DURING RF DELIVERY, WHICH CAN RESULT IN THE OCCURRENCE OF UNINTENDED CARDIAC STIMULATION. THESE CONDITIONS ARE DESCRIBED IN THE BSC WHITE PAPER "DC VOLTAGE GENERATION ACROSS DIAGNOSTIC ELECTRODES THROUGH INTERACTIONS BETWEEN EP RECORDING SYSTEMS, PACING STIMULATORS, AND RF GENERATORS." BOSTON SCIENTIFIC COMMUNICATED THIS INFORMATION IN A CUSTOMER LETTER TO ALL OF ITS EP CUSTOMERS IN AUGUST 2006. THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THIS DEVICE. ADD'L PMA/510(K) #P920047.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN ABLATION PROCEDURE WITH AN 8F BLAZER CATHETER, THE GROUNDING PADS WERE NOT PLUGGED IN WHILE USING A ST. JUDE NAV-X MAPPING SYSTEM. AFTER DELIVERING POWER FOR 25 SECONDS, THE PATIENT WENT INTO A-FIB WHICH TERMINATED ON ITS OWN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II THERAPEUTIC ABLATION CATHETER LPB BOSTON SCIENTIFIC DP TECHNOLOGIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other PRUCKA RECORDING SYSTEM| BSC XP GENERATOR AND APM| ST. JUDE NAVX MAPPING SYSTEM| BLOOM STIMULATOR