NIM® EMG ELECTRODE

Additional Manufacturer Narrative

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY ( LEFT / RIGHT COCHLEAR ) , 20 MINUTES INTO DRILLING WITH IRRIGATION, VOCALIS 2 WAS DISPLAYING EXCESSIVE NOISE. THE NIM SOFTWARE WAS VERSION 1.7.5. NIM PLUGGED INTO OWN WALL OUTLET ON THE OTHER SIDE OF ROOM. THE SURGEON USED BOVI AND STRYKER CONSOLE (AND DRILL) PLUGGED INTO THE SAME WALL OUTLET (NO POWER STRIP BEING USED). MUTING PROBE USED ON BOVI WITH LOOP CORRECT, BUT MUTING CLAMP IS MISSING A PIECE. THE PATIENT INTERFACE BOX WAS WIRED, LEAD PLACEMENT VERIFIED ALSO SWAPPED RED LEADS ON PI BOX (SWITCHED NEGATIVE AND POSITIVE). THE DRILL SPEED START AROUND 65-700 RPM AND UPPED IT WHEN WENT TO SMALLER DRILL BIT. ALSO, INTERMITTENT OUT OF MEASUREMENT RANGE ERROR COMES UP, BUT WOULD CLEAR UP. THE SURGEON THEN MOVED TO OTHER SIDE ( RIGHT COCHLEAR ), USED NEW LEADS, NIM PLUGGED INTO THE SAME WALL OUTLET, BOVI NOT USED, USED STRYKER CONSOLE, AND DRILL (WENT UP TO 8,000 RPM) AND EXCESSIVE NOISE DID NOT HAPPEN ON THIS SIDE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

B5 : ADDITIONAL INFORMATION 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.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED THAT DURING EVENT, THE PATIENT WASN'T REPOSITIONED BUT AFTER THE INCIDENT HAS TRANSPIRED THE PROCEDURE PROCEEDED TO THE OPPOSITE SIDE. THIS WAS A BILATERAL COCHLEAR IMPLANT PROCEDURE. UPON FINISHING ONE SIDE OF THE PROCEDURE, THE SURGICAL TEAM DECIDED TO BREAK DOWN THE DRAPES AND SETUP THE OPPOSITE SIDE WITH NEW DRAPES, ELECTRODES AND SO ON. THE 'OUT OF MEASUREMENT RANGE' MESSAGE WAS NOT ON SCREEN DURING THE TIME OF EVENT BUT HAPPENED BEFORE THE INCIDENT.

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED THAT NO EXCESSIVE NOISE WAS ON THE OPPOSITE SIDE WITH NEW ELECTRODES.

Additional Manufacturer Narrative

B5: ADDITIONAL INFORMATION RECEIVED. H6: CODES UPDATED. PREVIOUSLY APPLIED CODES FDC D16 AND FDR C21 ARE NO LONGER APPLICABLE. 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.