BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR EPT-1000XP REFURBISHED

    MDR report key: 1066620 · Received June 27, 2008

    Report

    Report Number
    2953184-2008-00020
    Event Type
    Injury
    Date Received
    June 27, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC, EP TECHNOLOGIES
    Product Code
    LPB
    PMA / PMN Number
    P80003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES ARE NOT EXPECTED TO BE RETURNED AS THEY ARE STILL IN USE AT THE HOSPITAL: MAESTRO 3000 CONTROLLER, MAESTRO 3000 POD, EPT-1000XP GENERATOR, EPT-1000XP APM.

    Description of Event or Problem · 1

    IN 2008, THE FOLLOWING INCIDENT WAS REPORTED TO BOSTON SCIENTIFIC BY THE USER FACILITY; WHEN EP PHYSICIAN INITIATED AN ABLATION TO THE PATIENT WITH THE EPT-1000XP CARDIAC ABLATION SYSTEM, THE PATIENT EXPERIENCED A RUN OF SVT. WHEN THE ABLATION WAS DISCONTINUED, THE PATIENT SHORTLY RETURNED TO NORMAL PACED BEAT. THE ABLATION WAS REPEATED USING THE MAESTRO 300 CARDIAC ABLATION SYSTEM UNIT AND THE SAME PHENOMENON OCCURRED. THE PHYSICIAN STATED THAT HE FELT THERE WAS AN UNKNOWN 60 CYCLE PRESENT IN THE PATIENT'S TRACING WHICH WAS THOUGHT TO BE THE REASON THE PATIENT EXPERIENCED A SUDDEN RUN OF SVT.

    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 Other MICROPACE STIMULATOR| (MFG REPORT #2953184-2008-00021)| PHILLIPS MRX DEFIBRILLATOR| MAESTRO 3000 POD (MFG REPORT #2953184-2008-00017)| XP APM (MFG REPORT #2953184-2008-00018)| (MFG REPORT #2953184-2008-00019)| MAESTRO 3000 CONTROLLER| BLAZER II XP CATHETER| PRUCKA RECORDING SYSTEM