NIM® EMG ELECTRODE

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE TIROIDECTOMIA BILATERAL SURGERY STARTED WITH THE RIGHT VOCAL CORD ELECTRODE WITH NO RESPONSE. IT MARKED X ON THE ELECTRODE CHECK. THE ENDOTRACHEAL TUBE WAS MOVED AND OBTAINED A SIGNAL. THEN, SURGEON STIMULATED DIRECTLY ON THE NERVE AND THE EQUIPMENT INDICATED THAT THERE WAS NO NERVE. SURGEON WAS SURE IT WAS IN THE NERVE, SO HAD A COMPETITOR PRODUCT BROUGHT IN, WHICH FINALLY GAVE AN ANSWER THAT IT WAS IN THE NERVE. THEY CONTINUED THE SURGERY WITH COMPETITOR PRODUCT. AT THE END, THE TUBE AND THE PROBE WAS REMOVED FROM THE SURGICAL FIELD, PERFORMED THE TESTS WITH THE PATIENT SIMULATOR AND EVERYTHING WAS RESPONDING CORRECTLY. THERE WAS NO PATIENT IMPACT. THERE WAS SURGICAL DELAY OF 60 MINUTES AND THERE WAS NO PRODUCT DAMAGE. PATIENT HAS MEDICAL HISTORY OF CA. DE TIROIDES.

Additional Manufacturer Narrative

H3 : ANALYSIS OF PRODUCT 8227411 OF LOT# 0224013699 FOUND THAT VISUALLY, THERE WAS NO DAMAGE IN THE CONSTRUCTION OF THE DEVICES. ELECTRICALLY, THE RESISTANCE OF THE ORANGE AND VIOLET ELECTRODES FROM END TO END SHALL BE LESS THAN 2.0 OHMS AND THE ACTUAL MEASUREMENTS BETWEEN BOTH POLES WERE 2.0 AND 2.5 OHMS (ORANGE) AND 1.9 AND 2.0 OHMS (VIOLET) WHICH THE ORANGE ELECTRODES WERE OUT OF SPECIFICATION. IN ADDITION, THE VIOLET ELECTRODES HAD CONTINUITY BETWEEN EITHER POLE REGARDLESS OF THE MOLEX CONNECTOR (OPEN CIRCUIT). THE RESISTANCE OF THE GREEN GROUND AND RED/WHITE STIM ELECTRODES FROM END TO END SHALL BE LESS THAN 2.5 OHMS AND THE ACTUAL MEASUREMENTS WERE 2.0 OHMS (GREEN) AND 2.0 OHMS (RED) WHICH BOTH ELECTRODES WERE IN SPECIFICATION. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. H6 : CODES UPDATED, PREVIOUS APPLIED CODES FDM B17, FDR C20 AND FDC D14 NO LONGER APPLICABLE. H10 : REGULATORY REPORTS WITH REF # 1045254-2022-00546 AND 9612501-2022-01564 SUBMITTED FOR OTHER PRODUCTS INVOLVED IN THIS EVENT. 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.

Description of Event or Problem

ON FOLLOW-UP IT WAS REPORTED THAT STIMULUS ADJUSTED FIRST TO 0.8 AND THEN TO 1.0. THRESHOLD SET TO 100. NO BASELINE WAS PERFORMED. THE PATIENT'S NERVE INTEGRITY CHECKED BEFORE CLOSING THE SITE WITH COMPETITOR'S STIMULATOR. THERE WAS NO VISUAL AND/OR AUDIBLE INDICATORS TO ALERT THE USER TO THE PROBLEM AND THERE WAS NO ERROR CODE DISPLAYED. NO WAVEFORM DISPLAYED. A SHORT-ACTING RELAXANT WAS USED AND AFTER 30 MINUTES THE ANESTHESIOLOGIST PERFORMED THE TESTS WITH THE EQUIPMENT INTENDED FOR THIS PURPOSE AND IT WAS FOUND THAT THE MUSCLE RELAXANT WAS NO LONGER PRESENT.