77ETN MEDTRONIC XOMED, INC.

REFERENCE MEDWATCH REPORT# 1045254-2010-00011 (DEVICE 2) FOR ADDITIONAL EQUIPMENT INVOLVED IN THIS EVENT. A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. THIS PRODUCT IS BEING USED FOR TREATMENT. AT PRESENT, THE PT IS GETTING SOME NERVE SENSATION BACK. NO ADDITIONAL F/U CARE WAS REQUIRED AS A RESULT OF THIS EVENT. LESS THAN A HALF AN HOUR DELAY OF SURGERY OCCURRED WHILE DIAGNOSING THE PROBLEM WITH THE EQUIPMENT. AN ANALYSIS OF THE NIM 2.0 SYSTEM THAT WAS RETURNED TO MEDTRONIC SHOWED THAT THERE WAS A MISSING HEX NUT FROM THE CONNECTOR ON THE BACK OF THE MAINFRAME WHERE THE PT INTERFACE COMPONENT SCREWS IN. THE TWO SCREWS ON THE INTERFACE CABLE WERE SEVERELY BENT AND THE CABLE CONNECTOR WAS DAMAGED INDICATING MISHANDLING. THE FAILURE OF THE UNIT TO SIGNAL WAS RECREATED BY INSTALLING THE ONE SCREW AND MANIPULATING THE CABLE CONNECTION INTO THE BACK OF THE MAINFRAME. THE NIM SYSTEM DID NOT FUNCTION PROPERLY DUE TO THE DAMAGE AT THE CONNECTOR. AFTER REPLACING THE INTERFACE CABLE AND THE HEX NUT WITH WASHER ON THE BACK OF THE MAINFRAME, THE INTERFACE WAS SECURELY CONNECTED TO THE MAINFRAME. THE SYSTEM WAS THEN ELECTRICALLY TESTED AND FOUND TO BE WITHIN SPECIFICATION WITH NO OTHER FAULT FOUND. THE INSTRUCTIONS FOR USE STATEMENTS INCLUDE BUT ARE NOT LIMITED TO, THE NIM 2.0 DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILL, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES. REPAIR AND/OR MODIFICATION TO THE NIM-RESPONSE 2.0, OR ANY ACCESSORIES BY ANYONE OTHER THAN QUALIFIED SERVICE PERSONNEL MAY SIGNIFICANTLY COMPROMISE THE UNIT'S ABILITY TO MONITOR NERVE ACTIVITY AND/OR VOID THE EQUIPMENT WARRANTY. MEDTRONIC XOMED RECOMMENDS PREVENTATIVE MAINTENANCE AND SCREEN CALIBRATION SCHEDULED AT YEARLY INTERVALS. A REVIEW OF THE COMPLAINT HISTORY INDICATES NO TRENDS FOR THIS PRODUCT. NO ANOMALIES WERE FOUND IN THE MFG RECORDS. NO OTHER SERVICE AND REPAIR OR COMPLAINT RECORDS EXIST ON THIS NIM 2.0 SYSTEM.

DURING MASTOID SURGERY, THE DOCTOR STATED THE EQUIPMENT FAILED TO SIGNAL. THE PT WAS SUBJECTED TO SOME FACIAL NERVE PARALYSIS.

REFERENCE MEDWATCH REPORT# 1045254-2010-00010 (DEVICE 1) FOR ADDITIONAL EQUIPMENT INVOLVED IN THIS EVENT. A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. THIS PRODUCT IS BEING USED FOR TREATMENT. AT PRESENT, THE PT IS GETTING SOME NERVE SENSATION BACK. NO ADDITIONAL F/U CARE WAS REQUIRED AS A RESULT OF THIS EVENT. LESS THAN A HALF AN HOUR DELAY OF SURGERY OCCURRED WHILE DIAGNOSING THE PROBLEM WITH THE EQUIPMENT. AN ANALYSIS OF THE NIM 2.0 SYSTEM THAT WAS RETURNED TO MEDTRONIC SHOWED THAT THERE WAS A MISSING HEX NUT FROM THE CONNECTOR ON THE BACK OF THE MAINFRAME WHERE THE PT INTERFACE COMPONENT SCREWS IN. THE TWO SCREWS ON THE INTERFACE CABLE WERE SEVERELY BENT AND THE CABLE CONNECTOR WAS DAMAGED INDICATING MISHANDLING. THE FAILURE OF THE UNIT TO SIGNAL WAS RECREATED BY INSTALLING THE ONE SCREW AND MANIPULATING THE CABLE CONNECTION INTO THE BACK OF THE MAINFRAME. THE NIM SYSTEM DID NOT FUNCTION PROPERLY DUE TO THE DAMAGE AT THE CONNECTOR. AFTER REPLACING THE INTERFACE CABLE AND THE HEX NUT WITH WASHER ON THE BACK OF THE MAINFRAME, THE INTERFACE WAS SECURELY CONNECTED TO THE MAINFRAME. THE SYSTEM WAS THEN ELECTRICALLY TESTED AND FOUND TO BE WITHIN SPECIFICATION WITH NO OTHER FAULT FOUND. THE INSTRUCTIONS FOR USE STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO, THE NIM 2.0 DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILL, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES. REPAIR AND/OR MODIFICATION TO THE NIM-RESPONSE 2.0, OR ANY ACCESSORIES BY ANYONE OTHER THAN QUALIFIED SERVICE PERSONNEL MAY SIGNIFICANTLY COMPROMISE THE UNIT'S ABILITY TO MONITOR NERVE ACTIVITY AND/OR VOID THE EQUIPMENT WARRANTY. MEDTRONIC XOMED RECOMMENDS PREVENTATIVE MAINTENANCE AND SCREEN CALIBRATION SCHEDULED AT YEARLY INTERVALS. A REVIEW OF THE COMPLAINT HISTORY INDICATES NO TRENDS FOR THIS PRODUCT. NO ANOMALIES WERE FOUND IN THE MFG RECORDS. NO OTHER SERVICE AND REPAIR OR COMPLAINT RECORDS EXIST ON THIS NIM 2.0 SYSTEM.

DURING MASTOID SURGERY, THE DOCTOR STATED THE EQUIPMENT FAILED TO SIGNAL. THE PT WAS SUBJECTED TO SOME FACIAL NERVE PARALYSIS.

THE DOCTOR WAS PERFORMING A CRANIAL CASE WITH ACTIVE NERVE MONITORING USING THE NIM, AND COMPLETED THE SURGERY WITH NO DELAYS AND NO INDICATION OF A PATIENT INJURY OR DEVICE MALFUNCTION. THE DOCTOR WAS NOT AWARE THAT THE PATIENT'S FACIAL NERVE WAS DAMAGED UNTIL SOMETIME AFTER THE SURGERY, WHEN THE PATIENT SHOWED SIGNS OF FACIAL PALSY. THE FACILITY STATED THAT A NERVE MAY HAVE BEEN CLIPPED DURING THE PROCEDURE.

THIS PRODUCT WAS BEING USED FOR TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. A FACILITY CONTACT STATED THAT THEY WERE NOT RELEASING INFORMATION ON THE PATIENT'S CURRENT CONDITION, INCLUDING WHETHER OR NOT IT WAS TEMPORARY OR PERMANENT PALSY, AND THEY WILL NOT BE RETURNING THE DEVICE TO MEDTRONIC AT THIS TIME. A "PRODUCT PROBLEM" HAS NOT BEEN INDICATED OR CONFIRMED. THE FACILITY REPORTED THAT THE OPERATING ROOM WHERE THE NIM DEVICE WAS BEING USED IS LOCATED OVER A ROOM THAT CONTAINS AN MRI UNIT. MEDTRONIC RECOMMENDED TO THE FACILITY TO SURVEY THE OPERATING ROOM FOR EMI / RF INTERFERENCE BECAUSE THE RECOMMENDED SEPARATION DISTANCE FROM EQUIPMENT SUCH AS A MRI COULD BE AS MUCH AS 75 FEET, AS SPECIFIED IN THE USER'S MANUAL. THE USER MANUAL FOR THE NIM RESPONSE STATEMENTS INCLUDE BUT ARE NOT LIMITED TO, THE RECOMMENDED SEPARATION OF THE NIM RESPONSE FROM FIXED, MOBILE, OR PORTABLE ELECTROMAGNETIC OR RF GENERATING DEVICES CAN BE CALCULATED BY USING A FORMULA THAT IS INCLUDED IN THE USER MANUAL. A CHART IS INCLUDED WITH RECOMMENDED DISTANCES UP TO 23 METERS OR 75 FEET WITH VARIABLES INCLUDING WATTS AND FREQUENCY OF THE TRANSMITTER. NOTE: THESE GUIDELINES MAY NOT APPLY IN ALL SITUATIONS. ELECTROMAGNETIC PROPAGATION IS AFFECTED BY ABSORPTION AND REFLECTION FROM STRUCTURES, OBJECTS, AND PEOPLE. TO ASSESS THE ELECTROMAGNETIC ENVIRONMENT DUE TO A FIXED RF TRANSMITTER, AND ELECTROMAGNETIC SITE SURVEY SHOULD BE CONSIDERED. ELECTROMAGNETIC IMMUNITY LEVELS OF THE NIM RESPONSE ARE INCLUDED IN THE USER MANUAL AND REFERENCES TO SPECIFIC IEC IMMUNITY TESTS.