PATIENT INTERFACE NIM4CPB1 NIM 4.0

Additional Manufacturer Narrative

CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6) UDI#: (B)(4); PRODUCT ID: NIM4CM01, SERIAL/LOT #: (B)(6) UDI#: (B)(4). 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 PATIENT INTERFACE WAS NOT CONNECTING. THERE WAS NO KNOWN PATIENT IMPACT.

Additional Manufacturer Narrative

B5: SECTION B5 HAS BEEN CORRECTED. H3 :NIM PATIENT INTERFACE (B)(6) ANALYSIS OBSERVED NO FAULT FOUND. H6: CODES B01 AND C19 HAS BEEN UPDATED FOR PATIENT INTERFACE SERIAL NO (B)(6). THE PREVIOUSLY UPDATED CODES B17 AND C20 WERE NO LONGER APPLICABLE. H3: NIM PATIENT INTERFACE (B)(6) ANALYSIS FOUND THAT A REVERSE ORIENTATION WIRING FAILURE OCCURRED DUE TO A DEFECTIVE MAIN PCBA. H6: CODES B01 AND C0201 HAS BEEN UPDATED FOR PATIENT INTERFACE SERIAL NO (B)(6). THE PREVIOUSLY UPDATED CODES B17 AND C20 WERE NO LONGER APPLICABLE. H3: NIM CONSOLE (B)(6) ANALYSIS FOUND THAT DEFECTIVE PMA PCBA. H6: CODES B01 AND C0201 HAS BEEN UPDATED FOR NIM CONSOLE SERIAL NO (B)(6). THE PREVIOUSLY UPDATED CODES B17 AND C20 WERE NO LONGER APPLICABLE. H6: CODES E2403 AND F2601 HAS BEEN UPDATED. G2: REPORT SOURCE WAS NOT OUTSIDE OF US. 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 PRIOR TO PROCEDURE NIM PATIENT INTERFACE WAS NOT CONNECTING WITH NIM CONSOLE, EITHER THROUGH A WIRELESS CONNECTION OR A HARD-WIRED CONNECTION. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H6: CODE D20 HAS BEEN UPDATED FOR PATIENT INTERFACE SERIAL NO (B)(6). THE PREVIOUSLY UPDATED CODE D16 WERE NO LONGER APPLICABLE. H6: CODE D02 HAS BEEN UPDATED FOR NIM PATIENT INTERFACE SERIAL NO (B)(6) AND NIM CONSOLE SERIAL NO (B)(6). THE PREVIOUSLY UPDATED CODE D16 WERE 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.