BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X  EP SYSTEM FIELD FRAME

    MDR report key: 16876386 · Received May 5, 2023

    Report

    Report Number
    2184149-2023-00095
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DQK
    UDI-DI
    05415067032195
    PMA / PMN Number
    K202066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3. ONE ENSITE X AMPLIFIER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THE FRONT PORTS AND CHASSIS WERE FREE OF PHYSICAL DAMAGE. VISUAL INSPECTION OF THE REAR PORTS REVEALED THAT THE CAT5E (ETHERNET SFP) WAS MISSING ON RETURN. FOR EVALUATION PURPOSES, PORT 3 WAS TEMPORARILY INSTALLED WITH A KNOWN GOOD CAT5E SMALL FORM-FACTOR PLUGGABLE (SFP). THE AMPLIFIER WAS POWERED ON AND BOOTED TO A SOLID GREEN ¿READY¿ LIGHT EMITTING DIODE (LED) STATUS. THIS INDICATED THE AMPLIFIER PASSED THE POWER-ON-SELF-TEST (POST) AND THEN SUCCESSFULLY COMMUNICATED WITH THE TEST STATION TRACKER SOFTWARE. A FIELD FRAME, PATIENT REFERENCE SENSORS (PRS-A SINGLE, PRS-P TRIPLE), AND A WET LAB, WERE ALL CONNECTED INTO A MAGNETIC STUDY WITHIN TRACKER. AS THE IDENTIFICATION OF THE EEPROM WAS INITIATED, THE NDI BOARD COULD NOT DETECT THE SENSORS. THIS SYMPTOM WAS THEN ISOLATED TO THE SENSOR CONTROL UNIT (SCU) BOARD BY MEANS OF TEMPORARY REPLACEMENT WITH A KNOWN GOOD SCU. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO ELECTRICAL DAMAGE TO THE SCU BOARD.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED EVENT WERE IDENTIFIED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ELECTRICAL PROBLEM AND SUBSEQUENT CANCELLATION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING AN ATYPICAL ATRIAL FLUTTER ABLATION PROCEDURE, AN ERROR MESSAGE WAS NOTED STATING: "MAGNETIC GENERATOR NOT CONNECTED" AND THE PROCEDURE WAS CANCELLED. CONNECTIONS WERE CHECKED AND IT WAS NOTED THAT THE CABLE CONNECTION TO THE FIELDFRAME WAS NOT CONNECTED PROPERLY. THE PINS IN THE CABLE WERE BENT AND TOUCHING ONE ANOTHER. THE CABLE WAS DISCONNECTED FROM THE AMPLIFIER, AND THE PINS WERE BENT BACK INTO THE NORMAL POSITION. THE SYSTEM WAS REBOOTED MULTIPLE TIMES, BUT THE ISSUE PERSISTED. THE FIELD FRAME AND CABLE WERE THEN EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. AS A POSSIBLE RIGHT SIDED TACHYCARDIA WAS SEEN ON THE INSERTED CATHETERS, IT WAS DECIDED TO MAP THE RIGHT ATRIUM IN NAVX MODE WITHOUT SENSOR FUNCTION. A POSSIBLE SUBSTRATE WAS SEEN, TOGETHER WITH AN ACTIVATION MAP THAT COULD INDICATE RIGHT SIDED ATYPICAL FLUTTER. ABLATION WAS PERFORMED USING TACTICATH SE CATHETER AND PLUGGED IN AS A DIAGNOSTIC CATHETER ON THE 20 PIN PINBOARD, SINCE IT WAS NOT SHOWN ON ENSITE DUE TO AN ISSUE WITH MAGNETICS. ABLATION WAS PERFORMED BUT THE TACHYCARDIA PERSISTED. ENTRAINMENT PACING WAS PERFORMED, INDICATING LEFT SIDED TACHYCARDIA. IT WAS DECIDED NOT TO INSERT CATHETERS INTO THE LEFT ATRIUM DUE TO SYSTEM ISSUES AND THE PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428559 ENSITE X  EP SYSTEM FIELD FRAME COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL, INC. ENSITE-FF-01 7914873 05415067032195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown