NIM® EMG ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT, DURING THE OPERATION, IN NIM3.0 THE NERVE MONITOR KEPT ALARMING, COULD NOT BE USED NORMALLY, AND COULD NOT DETECT WHETHER THE FACIAL NERVE WAS DAMAGED. THE PATIENT DEVELOPED FACIAL PARALYSIS AFTER THE OPERATION, AND THE PATIENT'S FACIAL PARALYSIS SYMPTOMS DID NOT ALLEVIATE 3 MONTHS AFTER THE OPERATION. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT WITH EXTENDED TIME OF TWENTY MINUTES. ON FOLLOW UP IT WAS REPORTED THAT PROCEDURE WAS EAR MASTOID SURGERY, THE ELECTRODE USED WERE SUBCUTANEOUS ELECTRODE. THE MACHINE KEPT ALARMING THROUGHOUT THE WHOLE PROCESS, TRIED TO RESTART MACHINE TO ACCESS DURING THE OPERATION, BUT THE PROBLEM STILL COULD NOT BE SOLVED. ACCORDING TO THE SURGEON'S DESCRIPTION, THE FACIAL NERVE WAS CONNECTED DURING THE OPERATION, AND SUBCUTANEOUS ELECTRODE WAS USED TO PROBE, AND AN ALARM WOULD SOUND NO MATTER WHERE IT WAS LOCATED, FROM THE BEGINNING OF THE OPERATION TO THE END OF THE OPERATION. DUE TO THE FAILURE OF THE DETECTION, IT WAS IMPOSSIBLE TO JUDGE THE LOCATION OF THE NERVE AND WHETHER IT WAS DAMAGED DURING THE OPERATION. THEREFORE, THE SURGEON BELIEVED THAT THE FACIAL NERVE WAS DAMAGED DUE TO THE MACHINE PROBLEM. AT PRESENT, THERE IS NO GOOD INTERVENTION TO SOLVE THIS PROBLEM. THIS KIND OF INJURY IS INCURABLE AND PERMANENT.

Additional Manufacturer Narrative

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.

Additional Manufacturer Narrative

H6: ANNEX A CODE HAS BEEN UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.