NIM® EMG ELECTRODE

Additional Manufacturer Narrative

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

Description of Event or Problem

A HEALTHCARE PROFESSIONAL (CHP) REPORTED THAT INTRA OP WHILE PERFORMING THYROIDECTOMY, THE DEVICE DID NOT SEND ANY ALARM WHEN THE ELECTRODE FELL OFF THE PATIENT. THE PATIENT SUFFERED AN INJURY OF NERVE DAMAGE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. ADDITIONAL INFORMATION RECEIVED STATES THAT IN THE MIDDLE OF THE OPERATION THE ELECTRODE WHICH IS INSERT INTRAMUSCULARLY IN THE PATIENTS ARM FELL OUT OF THE PATIENT. IT WAS DISCOVERED IN THE MIDDLE OF THE OPERATION THAT THE ELECTRODE HAD FALLEN OFF FROM THE PATIENT. DURING THE PROCEDURE THEY WOULD GET AN EXPECTED WAVEFORM INTERMITTENTLY, SO THEY CHECKED THE VAGUS NERVE TWICE UNDER THE OPERATION. THE RIGHT SIDE NERVE WAS CUT AND WAS SUTURED; IT WILL REQUIRE ADDITIONAL MEDICAL INTERVENTIONS TO RESOLVE. THE PATIENT IS CURRENTLY HOME, RECOVERING FROM THE OPERATION. THE DEVICE HAS THE LATEST SOFTWARE AS THE IT WAS RECENTLY WAS PURCHASED.

Additional Manufacturer Narrative

CONTINUATION OF D10 - SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID #NIM4CM01; SERIAL NUMBER # (B)(6); LOT NUMBER #222622462; UNIQUE IDENTIFIER (UDI) (B)(4); PRODUCT ID #NIM4CPB1; SERIAL NUMBER # (B)(6); LOT NUMBER #222429056; UNIQUE IDENTIFIER (UDI) (B)(4); 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

ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT A STIMULUS PROBE WAS USED. IT WAS FURTHER ADDED THAT DURING THE PROCEDURE, THE NIM CONSOLE GAVE A SOUND WHILE STIMULATING THE NERVE. WHEN THE PROBLEM (SILENCE) STARTED TO INCREASE, THE USER STARTED TO LOOK AROUND AND IT WAS NOTICED THAT A ELECTRODE FROM A PATIENT HAD FELL OFF. THERE WERE NO WARNING SIGN "ELECTRODE OFF" WAS GIVEN ON DISPLAY. TROUBLESHOOTING WAS DONE BY JUST CHECKING THE CABLES, BUT THE FAILURE WAS IDENTIFIED AT THE END OF THE PROCEDURE. THE NIM VITAL CONSOLE AND NIM VITAL PATIENT INTERFACE WERE INVOLVED IN THE EVENT. THERE WAS NO INVOLVEMENT OF APS ELECTRODE IN THE EVENT.