BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE PREAMPLIFIER

    MDR report key: 7184901 · Received January 11, 2018

    Report

    Report Number
    1045254-2018-00018
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 15, 2017
    Report Date
    March 17, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169071933
    PMA / PMN Number
    K050798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THE PATIENT HAD THE RETAINED ELECTRODE FRAGMENT REMOVED FROM HER RIGHT TIBIA ON (B)(6) 2018 TO EXPEDITE HEALING. ON (B)(6) 2018, DURING HER 6 MONTH FOLLOW-UP, THE PATIENT REPORTED 0 PAIN AND THE RIGHT TIBIA SHOWED INCREASED EVIDENCE OF HEALING AFTER FOREIGN BODY REMOVAL.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: - 945ECLC: CONTROLLER 945ECLC ECLIPSE, S/N (B)(4), LOT 205536466 MANUFACTURED: 2011/12/14 UDI: (B)(4); 945EEX901: EXTENDER 945EEX901 STIMULATOR, S/N (B)(4), LOT 1709260 MANUFACTURED: 2011-06-22 UDI: (B)(4). PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; EVALUATION EXPECTED BUT NOT YET BEGUN. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: -- PRODUCT ID: 945DAQ916, SERIAL (B)(4), LOT NO: 205498264. SERVICE AND REPAIR FOUND THAT CHANNELS 14, 16 AND 17 ARE ALL FAULTY ON THE ELECTRODE BOARD ON THE DAQ PREAMPLIFIER; THE RESISTOR BELOW THE DIODE AT D14 IS DAMAGED ON THE ELECTRODE BOARD. REPLACED ALL BOARDS AND AS A PRECAUTION, PLACED IN A RUN-IN TEST FOR 8 HOURS. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. THE FAULTY BOARDS FROM THE 945DAQ916 THAT WERE REMOVED BY SERVICE AND REPAIR WERE SENT FOR FURTHER INVESTIGATION BY OUR ENGINEERS. CONCLUSION: A CURRENT SURGE FROM THE BOVIE FOUND A PATH THROUGH THE ELECTRODE (CHANNEL 14) TO THE GROUND OF THE DAQ916 AND BURNED THE CONNECTOR CAUSING A CIRCUIT FAILURE TO 945DAQ916 CHANNELS 14, 16, 17. THIS IS EVIDENT FROM THE FACT THAT THE POWER RAILS OF THE 945DAQ916 WERE STILL FUNCTIONING AND SUPPLYING POWER TO THE REST OF THE DEVICE AND THE OTHER CHANNELS WERE STILL FUNCTIONING. ALSO, U27B (OPERATIONAL AMPLIFIER) WAS FOUND TO BE SHORTED FROM ITS OUTPUT PIN TO ITS INPUT PIN, WHICH IS CONSISTENT WITH AN OUTSIDE CURRENT SOURCE FORCING ITS WAY THROUGH THE OPAMP, R65 TO THE GROUND OF THE 945DAQ916. PRODUCT ID: 945ECLC, SERIAL (B)(4), LOT NO: 205536466. SERVICE AND REPAIR FOUND NO FAULT WITH THE ECLIPSE CONTROLLER. IT WAS SUCCESSFULLY TESTED TO MANUFACTURING SPECIFICATIONS. PRODUCT ID: 945EEX901, SERIAL (B)(4), LOT NO: 1709260. SERVICE AND REPAIR FOUND NO FAULT WITH THE ECLIPSE EXTENDER. IT WAS SUCCESSFULLY TESTED TO MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CNIM (CERTIFIED NEUROPHYSIOLOGICAL INTRAOPERATIVE MONITOR) THAT ABOUT 20 MINUTES INTO AND ANTERIOR LUMBAR INTERBODY FUSION (ALIF) THE SURGEON USED THE BOVIE CAUTERY, WHICH CREATED THE EXPECTED ARTIFACT. A MINUTE LATER THE ARTIFACT WAS STILL PRESENT, BUT WHEN INQUIRING AS TO WHY THE BOVIE WAS STILL IN USE, HE WAS TOLD IT WAS NOT. ¿THERE WAS A SURGE THAT TOOK OUT ALL THE EQUIPMENT.¿ HE CHECKED THE BOVIE GROUNDING PAD AND IT FELT FINE; IT WAS NOT WET OR LOOSE. THE SURGE CAUSED THE DAQ PRE-AMP TO ¿BLOW¿. THEY CHECKED ALL LEADS, CONNECTIONS, UNPLUGGED AND RE-PLUGGED EVERYTHING, AND EVERYTHING APPEARED TO BE WORKING, EXCEPT THE DAQ. IT WAS CONFIRMED THAT THE EQUIPMENT WAS PLUGGED INTO A SURGE PROTECTOR; ALSO, NONE OF THE NIM COMPONENTS, CABLES OR CORDS WERE TOUCHING ANY OF THE ELECTRICAL EQUIPMENT OR THE BOVIE EQUIPMENT. THE CAUSE OF THIS ISSUE IS BELIEVED TO BE THAT THE BOVIE CURRENT, 240 VOLTS, WENT TO THE BOVIE GROUNDING PAD, HOWEVER IT WASN¿T WORKING CORRECTLY. AT THAT POINT THE CURRENT USED THE ELECTRODES (RECORDING NEEDLES; NON-MEDTRONIC PRODUCT) AS THE GROUND; THE CURRENT USED THE ELECTRODE NEEDLES INSTEAD OF THE BOVIE PAD TO COMPLETE THE CIRCUIT. ANESTHESIA SAW THE SURGE AS WELL, THE MONITORING EQUIPMENT DISPLAYED CURRENT BEING CARRIED THROUGH PATIENT. BECAUSE OF THIS SURGE OF ELECTRICAL CURRENT, THE PATIENT SUSTAINED 3 BURNS IN TOTAL; THEY WERE SMALL, LIKE THE TIP OF A PENCIL ERASER. THE BURNS WERE LOCATED AT THE ELECTRODE SITES ON THE LEFT QUAD ON THE RECORDING ELECTRODE (+ SIDES), RIGHT TIBIA ANTERIOR AND RIGHT GASTROCNEMIUS. LARGEST, DEEPEST, LEFT QUAD NEXT TO PATIENT¿S BONY PAD. WHEN REMOVING THE ELECTRODES, THEY DISCOVERED THAT THE RIGHT ANTERIOR TIBIA ELECTRODE BURNT OFF; THE PATIENT WAS SENT TO X-RAY AND THEY WERE ABLE TO SEE THE TIP, BUT DECIDED TO LEAVE IT IN. THE FRAGMENT WAS LOCATED AWAY FROM COMPARTMENT, IT WILL NOT MIGRATE. OINTMENT AND DRESSING WAS APPLIED TO THE 3 SITES, THEY WILL BE ALLOWED TO HEAL ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28187 NIM-ECLIPSE PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 945DAQ916 205498264 00643169071933

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention