APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

H3: ANALYSIS FOUND THAT THE C-CLIP CONTACT WAS NOT EXPOSED/FLUSH WITH THE INSIDE DIAMETER OF THE CLIP BODY UPON RETURN. THE CONTACT WAS RECESSED INSIDE THE CLIP BODY BY 0.06 INCHES (FROM THE CLIP OPENING TO THE DISTAL TIP OF THE CONTACT). CONTAMINATION WAS OBSERVED ON THE OUTSIDE DIAMETER OF THE CLIP BODY. THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND THE ACTUAL MEASUREMENT WAS 11.6 OHMS WHICH WAS IN SPECIFICATION. THE COMPLAINT WAS CONFIRMED, DUE TO AN OUT OF SPECIFICATION CONDITION. H6: PREVIOUSLY SUBMITTED CODES FDM B17, FDR C20 AND FDC D16. 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

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 INTRAOPERATIVELY, THE APS ELECTRODE WAS CONNECTED TO THE NIM VITAL MACHINE, THE ELECTRODE COULD BE DETECTED BUT THERE WAS NO SIGNAL. REPEATED DEBUGGING DID NOT IMPROVE THE SITUATION, SO THE ONLY OPTION WAS TO REPLACE THE CONSUMABLE. THERE WAS NO PATIENT IMPACT.

Description of Event or Problem

IT WAS REPORTED THAT INTRA-OP, THE APS ELECTRODE WAS CONNECTED TO THE NIM VITAL MACHINE, THE ELECTRODE COULD BE DETECTED BUT THERE WAS NO SIGNAL. REPEATED DEBUGGING DID NOT IMPROVE THE SITUATION, SO THE ONLY OPTION WAS TO REPLACE THE CONSUMABLE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H6: UPDATED THE FDC CODE. PREVIOUSLY SUBMITTED FDC D03 IS 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.