NIM® EMG ELECTRODE

Additional Manufacturer Narrative

H3:PRODUCT ANALYSIS FOUND THAT UPON RECEIPT, THE PACKAGING CARTON WAS DAMAGED AND CONTAINED AN INSERT; ONE POUCH WITH GREEN AND RED/WHITE ELECTRODES; ONE POUCH WITH BLUE AND RED PAIRED ELECTRODES; AND ONE POUCH WITH ORANGE AND VIOLET PAIRED ELECTRODES. ALL POUCHES WERE OPEN ON TWO OF FOUR SIDES UPON RETURN. NO TRACES OF CONTAMINATION WERE OBSERVED ON THE RETURNED ELECTRODES. ELECTRICALLY, THE RESISTANCE REQUIREMENT FROM END TO END SHALL BE LESS THAN 2 OHMS. MEASURED VALUES WERE AS FOLLOWS: THE GREEN ELECTRODE MEASURED 1.1 OHMS; THE RED/WHITE ELECTRODE MEASURED 1.0 OHM; THE ORANGE PAIRED ELECTRODE MEASURED 1.5 OHMS AND 1.0 OHM; THE VIOLET PAIRED ELECTRODE MEASURED 1.1 OHMS AND 1.2 OHMS; AND THE RED PAIRED ELECTRODE MEASURED 1.9 OHMS AND 1.9 OHMS, ALL OF WHICH WERE WITHIN SPECIFICATION. HOWEVER, TESTING OF THE BLUE PAIRED ELECTRODE REVEALED A SHORT CIRCUIT, AS CONTINUITY WAS OBSERVED BETWEEN BOTH POLES REGARDLESS OF MEASUREMENT POINTS. FURTHERMORE, X RAY ANALYSIS OF THE NEEDLE HOUSING REVEALED THAT THE INTERNAL POLES WERE TOUCHING, CONFIRMING THE SHORT CIRCUIT. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. H6: THE PREVIOUSLY APPLIED FDM B21 AND FRD C21 ARE NO LONGER APPLICABLE.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.

Additional Manufacturer Narrative

H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT BEFORE USE, THE ELECTRODE WAS UNABLE TO SENSE. THEY HAVE TRIED RECONNECTING, AND STILL THE ISSUE PERSISTS. THE PROCEDURE WAS COMPLETED BY RECONNECTING THE PROBE TO THE PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.