BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR EPT-1000XP REFURBISHED

    MDR report key: 859124 · Received June 4, 2007

    Report

    Report Number
    2953184-2007-00009
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 7, 2007
    Report Date
    May 7, 2007
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATIONAL INTERVIEWING, IT HAS BEEN ESTABLISHED THAT THE CONDITIONS THAT COULD LEAD TO AN UNINTENDED, RF INDUCED ARRYTHMIA WERE PRESENT DURING THE PROCEDURE. THESE CONDITIONS HAVE PREVIOUSLY BEEN DESCRIBED IN BOSTON SCIENTIFIC TECHNICAL PAPER, "DC VOLTAGE GENERATION ACROSS DIAGNOSTIC ELECTRODES THROUGH INTERACTION BETWEEN EP RECORDING SYS, PACING STIMULATORS, AND RF GENERATORS". THIS INFO WAS MAILED TO ALL BOSTON SCIENTIFIC ELECTROPHYSIOLOGY CUSTOMERS ON AUGUST 9, 2006. THE FINDING IN THE TECHNICAL PAPER WAS THAT THE LIKELY ROOT CAUSE WAS NOT RELATED TO A SPECIFIC RF GENERATOR, BUT RATHER THE PACING STIMULATOR CONVERTING RF TO POTENTIAL DC VOLTAGE WHICH MAY THEN BE DELIVERED TO THE PT THROUGH THE EP RECORDING SYS. BOSTON SCIENTIFIC HAS REVIEWED (2) TWO PT SAFETY NOTICED DISTRIBUTED BY FISCHER IMAGING CO, MFR OF BLOOM STIMULATOR MODELS DTU-2XX WHICH APPEAR TO CONFIRM THE BOSTON SCIENTIFIC STUDY. IT HAS BEEN ESTABLISHED BY FISHER IMAGING THAT THE BLOOM STIMULATOR IS THE ROOT CAUSE OF THE ISSUE. COMPLAINT HISTORY REVIEW HAS DETERMINED THERE WERE NO PREVIOUS SIMILAR COMPLAINT FROM THIS CUSTOMER; THERE WERE NO SIMILAR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 1

    AN EVENT WAS REPORTED TO BOSTON SCIENTIFIC SALES REP STATED AS: "ABLATION WITH NO GROUND PADS". WHEN THEY NOTICED, THERE WAS NO GROUND PADS ATTACHED TO THE PT, THEY APPLIED GROUND PADS. RF ENERGY WAS THEN DELIVERED. WHEN XP GENERATOR ABLATED FOR SEVERAL SECONDS UNINTENDED ARRYTHMIA OCCURRED WHICH WAS DESCRIBED AS : "RF ENERGY SEEMED TO BE PACING THE VENTRICLE FROM THE ABLATION SITE (LATERAL RIGHT ATRIUM) EACH TIME ENERGY CAME ON IT AND STAYED ON UNTIL WE CAME OFF". THE PT WAS FINE AND WAS RELEASED FROM THE HOSP SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR EPT-1000XP REFURBISHED RF GENERATOR LPB BOSTON SCIENTIFIC, EP TECHNOLOGIES 800XPR

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other BLOOM STIMULATOR| GE/PRUCKA RECORDING SYS| DEFIBRILLATOR| EPT-1000XP APM| BSC ABLATION CATHETER