NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY THAT CUSTOMER DISSECTED THE LEFT LOBE APPROPRIATELY WITHOUT INCIDENT AND WERE ABLE TO STIMULATE THE LARYNGEAL NERVE. HOWEVER, ON THE RIGHT LOBE THE NIM DID NOT STIMULATE THE LARYNGEAL NERVE ON THE PROXIMAL STUMP. THEY DID GET NERVE STIMULATION DURING THE DISSECTION OF THE LYMPH NODES AS WELL AS WHEN STIMULATING THE VAGUS NERVE. THEY WOKE HER UP AND DID A FIBEROPTIC LARYNGOSCOPY AND NOTED THERE WAS NO MOVEMENT OF EITHER VOCAL CORD. AT THAT POINT THEY DID A TRACHEOSTOMY AND SENT PATIENT TO ICU. THE PATIENT MIGHT HAVE LARYNGEAL NERVE INJURY. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). PATIENT WAS ALIVE WITH INJURY. THERE WAS SURGICAL DELAYS WHICH INCLUDED TROUBLESHOOTING MACHINE, ANESTHESIA ASSESSMENTS, AND LOOKING FOR THE NERVE. PATIENT HAD MEDICAL HISTORY OF MULTINODULAR GOITER. (B)(6) 2022: ON FOLLOW-UP IT WAS REPORTED THAT WHEN STIMULATION PROBE WAS PLACED ON THE NERVE, THERE WAS NO EXPECTED STIMULATING SOUND OR WAVEFORM ON THE MONITOR. THE RLN WAS INTACT ON THE LEFT, IT DID STIMULATE WELL PROXIMALLY BUT NOT VERY WELL DISTALLY. SURGEON DOES NOT RECALL A BASELINE NERVE FUNCTION BEING PERFORMED PRIOR TO REMOVING EACH LOBE. NIM DID NOT ALERT SURGEON BY EMITTING AN AUDITORY RESPONSE OR BY DISPLAYING WAVEFORMS ON MONITOR. STIMULUS CURRENT WAS SET TO DEFAULT SETTINGS. PATIENT WAS DISCHARGED HOME WITH HOME HEALTH SERVICES ON 12/17. PEG TUBE AND TRACHEOSTOMY TUBE REMAIN IN PLACE. SURGEON EXPECTS PATIENT TO REGAIN SWALLOWING FUNCTION AND EVENTUALLY VOCAL CORD FUNCTION BUT THIS MAY TAKE SOME TIME. MUSCLE RELAXANT SUCCINYLCHOLINE 20MG/ML ¿ 120MG GIVEN AT APPROX. 1304 AND SURGERY INCISION AT 1320.

Additional Manufacturer Narrative

REGULATORY REPORTS WITH REFERENCE # 1045254-2022-00798; 1045254-2023-00056 AND 1045254-2023-00057 WERE SUBMITTED FOR OTHER PRODUCTS INVOLVED IN THIS EVENT. MEDICAL SAFETY REVIEW STATES THAT SUCCINYLCHOLINE WAS USED AS THE PARALYTIC FOR INTUBATION; IT WAS A GIVEN APPROXIMATELY 15 MINUTES PRIOR TO THE SURGICAL INCISION, WHICH INDICATES THAT IT IS REASONABLE TO EXPECT THAT IT WOULD HAVE WORN OFF, ALLOWING FOR THE ELICITING OF EMG RESPONSES. (TYPICAL DURATION OF THE EFFECT OF THE MEDICATION IS 10-15 MINUTES.) PATIENT WAS DISCHARGED HOME WITH HOME HEALTH SERVICES. THEIR PEG TUBE (FEEDING TUBE THROUGH THE ABDOMEN) AND TRACHEOSTOMY TUBE REMAIN IN PLACE. THE SURGEON EXPECTS PATIENT TO REGAIN SWALLOWING FUNCTION AND EVENTUALLY VOCAL CORD FUNCTION, BUT THIS MAY TAKE SOME TIME. THE EVENT AND ITS SEVERITY ARE KNOWN AND LABELED PER IFU M988679A001 A, WHICH STATES THE FOLLOWING: THE NIM DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILLS, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES. IF PARALYZING ANESTHETIC AGENTS HAVE BEEN USED, PATIENT MUST REGAIN MUSCLE ACTIVITY PRIOR TO USE OF THE NIM-NEURO/RESPONSE 3.0 EMG MONITOR. TO LIMIT THE PARALYTIC EFFECT OF ANESTHETIC AGENTS, THE ANESTHESIOLOGIST SHOULD MONITOR TRAIN-OF-FOUR (TOF) TO PREVENT DI MINISHED EMG ACTIVITY. CONSULT ANESTHESIOLOGIST IF EMG CHANGES ARE OBSERVED. FALSE NEGATIVE RESPONSES (FAILURE TO LOCATE NERVE) MAY RESULT FROM: SHORTED EMG ELECTRODE OR CABLING (CONDUCTIVE PARTS OF APPLIED NEEDLE ELECTRODES OR CABLES CONTACTING EACH OTHER). PATIENT INTERFACE FUSE BLOWN AND NOT DETECTED (32 MA, 250 V. XOMED PART NO.: 8253075). PATIENT INTERFACE DEFECTIVE. INADEQUATE STIMULUS CURRENT. E. INADEQUATE CURRENT FOR STIMULATION OF NERVE THROUGH HARDWARE, SUCH AS STIMULUS DISSECTION INSTRUMENTS, MAY VARY BASED ON THE PHYSICAL SIZE, SHAPE CHARACTERISTICS, AND DESIGN OF THE HARDWARE AND PROXIMITY TO THE NERVE. SIMULTANEOUS STIMULATION OF THE NERVE AND THE SURROUNDING TISSUE, RESULTING IN CURRENT SHUNTING (INADEQUATE DELIVERY OF STIMULUS CURRENT TO TARGET NERVE TISSUE). FLATLINE ON THE EMG CHANNEL CAUSED BY SHORTED INTERNAL AMPLIFIER (CHARACTERIZED BY BASELINE ACTIVITY OF <(><<)> 3 V PEAK-TO-PEAK). EMG ELECTRODES NOT POSITIONED PROPERLY IN THE TARGET MUSCLES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.