APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, APS ELECTRODE WAS PLACED ON VAGUS NERVE, BUT NO SIGNAL COULD BE OBTAINED. FOLLOWING CLOSER INSPECTION OF THE APS ELECTRODE, NO STIMULATION CONTACT POINT (METAL) COULD BE SEEN IN THE LOOP. A REPLACEMENT ELECTRODE WAS OPENED, WHERE THE STIMULATION POINT WAS CLEARLY VISIBLE, BUT IT WAS NOT USED, AS THE SURGEON AT THAT POINT HAD IDENTIFIED THE RECURRENT NERVE. THE PROCEDURE WAS EXTENDED BY 45 MINS AND WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. H3: PRODUCT ANALYSIS FOUND VISUALLY, THERE WERE TWO OPENED SAMPLES RETURNED IN A ZIP LOCK BAG. THE FIRST SAMPLE HAD A CONTAMINATION ON THE C-CLIP. WHEN C-CLIP WAS OPEN, THERE WAS NO STIMULATION POINT. THE STIMULATION POINT WAS INSIDE THE C-CLIP BODY (IT WAS MISALIGNED WITH C-CLIP BODY). THE SAMPLE TWO HAD NO TRACE OF DAMAGE OR THE CONTAMINATION. WHEN OPENED THE SAMPLE TWO C-CLIP, THE STIMULATION POINT SHOWED. FOR FURTHER ANALYSIS, THE CONTINUITY CHECK WAS PERFORMED AND ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND FOR SAMPLE ONE WAS 12.4 OHMS AND FOR SAMPLE TWO 12.9 OHMS. IN THE RETURNED CONDITION, THERE WAS AN OUT OF SPECIFICATION CONDITION THAT WAS RELATED TO THE COMPLAINT. 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.