BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSITE SYSTEM

    MDR report key: 1067021 · Received June 27, 2008

    Report

    Report Number
    2184149-2008-00007
    Event Type
    Other
    Date Received
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    PMA / PMN Number
    K983456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SJM FIELD SERVICE ENGINEER REVIEWED THE SYSTEM IN 2008 AND REPORTED THE SYSTEM WAS FOUND TO BE FUNCTIONING PROPERLY. FOLLOWING VERIFICATION THAT THE ENSITE SYSTEM WAS PERFORMING NORMALLY, THE USER REPORTED TO THE SERVICE ENGINEER THAT ANOTHER CASE WAS PERFORMED USING A DIFFERENT LOT OF PATCHES. NO ADVERSE EVENT OCCURRED DURING THAT CASE. THE USER REPORTED THAT THERE WAS A CHANGE IN PROTOCOL WHICH HAS ABLATIONS TAKING PLACE AT 35-40 WATTS F/999 SECONDS. THE ABLATIONS ARE PERFORMED USING A STOCKERT GENERATOR AND AN ABLATION CATHETER OF UNK MANUFACTURE. THIS REPORT WAS REVIEWED WITH THE DIRECTOR FOR RESEARCH AND DEVELOPMENT FOR ENSITE HARDWARE WHO REPORTED THE FOLLOWING. WHEN THE ENSITE SYSTEM IS USED IN CONJUNCTION WITH THE STOCKERT GENERATOR, THE IMPEDANCE MEASUREMENT DISPLAYED BY THE STOCKERT GENERATOR MAY NOT BE ACCURATE CAUSING THE GENERATOR TO SHUT DOWN. THESE POWER/TEMPERATURE RELATIONSHIPS WILL BE THE SAME WITH OR WITHOUT THE ENSITE SYSTEM EVEN THOUGH THE DISPLAYED IMPEDANCE IS HIGHER WITH THE ENSITE SYSTEM CONNECTED. THIS IS BECAUSE THE STOCKER GENERATOR USES A SEPARATE CIRCUIT TO DISPLAY IMPEDANCE THAN IT USES TO CONTROL THE RF ENERGY. THE ENSITE TRAPS AFFECT THE IMPEDANCE MEASURING CIRCUIT AND NOT THE RF CONTROL CIRCUIT. AT THE RF FREQUENCY, THE TRAPS ARE LOW IMPEDANCE APPROX 3-5 OHMS. IF THE ENSITE SYSTEM DID AFFECT THE POWER DELIVERED, THE RELATIONSHIP OF POWER TO CATHETER TEMPERATURE WOULD CHANGE. BY CHANGING THE IMPEDANCE FREQUENCY OF THE GENERATOR TO 500KHZ, THE USER WILL BE ABLE TO SEE THAT THE POWER DELIVERED IS NOT AFFECTED BY THE ENSITE SYSTEM. THE STOCKERT GENERATOR USES 50KHZ TO MEASURE THE IMPEDANCE IN STANDBY MODE REGARDLESS OF THE IMPEDANCE FREQUENCY SETTING. IF SET TO 500KHZ, THE IMPEDANCE MEASUREMENT CIRCUIT SWITCHES TO 500KHZ WHEN RF TURNS ON. WHEN THIS HAPPENS, THE CORRECT IMPEDANCE WILL BE DISPLAYED.

    Description of Event or Problem · 1

    IT WAS REPORTED RADIO FREQUENCY (RF) BURNS WERE NOTED ON THE PT AT THE SITE OF THE RF DISPERSIVE PATCH. THIS PATCH IS NOT MANUFACTURED BY ST JUDE MEDICAL. TWO PHYSICIANS WERE INVOLVED WITH THE CASE, ONE PHYSICIAN, DR STATED THAT HE DOES BELIEVE THE ENSITE SYSTEM CONTRIBUTED TO EVENT. THE OTHER PHYSICIAN FEELS THE EVENT IS RELATED TO THE INTERACTION BETWEEN ESI, VALLEY LAB RF GROUNDING PATCHES AND THE STOCKERT GENERATOR. HE FEELS THAT THE STOCKERT IS ADJUSTING POWER AS A RESULT OF THE HIGH BASELINE IMPEDANCE SEEN WITH THE ESI/STOCKERT COMBINATION. HE INDICATED THAT THE BASELINE IMPEDANCE WITH ESI/STOCKERT IS ALWAYS GREATER THAN 200 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE SYSTEM ENSITE SYSTEM DRF ST. JUDE MEDICAL, ESI EE3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other