BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR EPT-1000XP REFURBISHED

    MDR report key: 1060633 · Received June 13, 2008

    Report

    Report Number
    2953184-2008-00015
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    December 16, 2007
    Report Date
    May 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN ESTABLISHED THAT CONDITIONS THAT COULD LEAD TO AN UNINTENDED, RF INDUCED ARRHYTHMIA 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 SUSCEPTIBLE 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 INFO IN A CUSTOMER LETTER TO ALL OF ITS EP CUSTOMERS IN AUG 2006. GENERATOR STILL BEING USED BY THE HOSP. OUR RECORDS INDICATE THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THE GENERATOR.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM USER FACILITY IN 2008, STATING "DURING PROCEDURE THERE WERE MULTIPLE CATHETERS IN THE HEART AND VOLTAGE WAS PASSED BETWEEN CATHETERS. CONFIRMED VALLEY PADS ARE BEING USED. CATH LAB DIR. CLAIMS THE CATHETER DID NOT TOUCH, AND CONFIRMED BLAZER AND ARRAY CATHETER WAS USED. HE BELIEVES GE RF FILTRATION BOX FOR PRUCKA MIGHT BE THE ISSUE. INJURY WAS MINOR AND NO REPORT MADE AT HOSP. NO ERROR CODES. ISSUE - UNK." THE FOLLOWING MONTH, THE PHYSICIAN WAS CONTACTED AND HE STATED; "DURING THE ABLATION PROCEDURE, DUE TO A SYS INTERACTION (NOT THE FAULT OF ANY SINGLE COMPONENT), ENERGY WAS TRANSFERRED TO ST. JUDE'S ARRAY CATHETER WHICH CAUSED THERMAL DAMAGE WHICH WAS CONTACTING THE HIS BUNDLE AND FREE WALL OF THE RVOT. THE PT WENT INTO ASYSTOLE AND SIMULTANEOUSLY A PORTION OF THE ST. JUDE ARRAY CATHETER PERFORATED THROUGH THE RVOT AFTER THE ONSET OF RF. ONE MINUTE AFTER THE PERFORATION, THE PT BLOOD PRESSURE DROPPED". THE PHYSICIAN BELIEVES THAT THE DESCRIBED ENERGY TRANSFER WAS DUE TO RECTIFICATION AS DESCRIBED IN THE BSC BLOOM-DC WHITE PAPER STUDY. THE PRUCKA RECORDING SYS WAS CONNECTED TO THE BLOOM STIMULATOR AND ROUTED FOR PACING. THE PHYSICIAN ALSO NOTED THAT EGM NOISE WAS SEEN EARLIER ON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R PRUCKA RECORDING SYSTEM| BLOOM STIMULATOR| ST JUDE ENSITE ARRAY CATHETER| BLAZER II ABLATION CATHETER