APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

THIS REPORT IS ALREADY SUBMITTED REGULATORY REP #:9612501-2024-00901. THIS IS CORRECTION INFORMATION RELATED TO THE PROVIDED REGULATORY REPORT. B.2.3 EVENT DATE: 2024-03-08. 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

A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRA-OPERATIVE ELECTRODES PLACED ON THE NERVE BUT THERE WERE NO STIMULATION. THE STIM RETURNED DID NOT SHOW 0 AND THE USER CONFIRMED THAT NOTHING CAUSED A LACK OF RESPONSE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H6: PREVIOUS CODES B01 WAS IN CORRECT AND SHOULD BE B17 HOWEVER THIS CODE IS NO LONGER VALID. 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.