APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. H3: PRODUCT ANALYSIS FOUND VISUALLY, THERE WAS NO DAMAGE TO THE PACKAGING CARTON. THERE WERE TRACES OF A BIOLOGICAL CONTAMINATION ON THE ELECTRODE AND THE C-CLIP. THERE WAS NO STIMULATION POINT FLUSH WHEN C-CLIP WAS OPEN. THE STIMULATION POINT WAS LOCATED INSIDE THE C-CLIP BODY, AND IT WAS MISALIGNED WITH C-CLIP BODY. FOR FURTHER ANALYSIS, THE CONTINUITY CHECK WAS PERFORMED AND ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END, AND ACTUAL MEASUREMENT WAS 12.6 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING INTRA-OP, CONTINUOUS MONITORING WAS PERFORMED USING AN APS ELECTRODE. HOWEVER, NO RESPONSE WAS OBTAINED. WHEN THE VAGUS NERVE WAS STIMULATED WITH MONOPOLAR STIMULATION, THE AMPLITUDE WAS CONFIRMED. THE APS ELECTRODE WAS CHECKED TO MAKE SURE IT WAS FIRMLY ATTACHED TO THE VAGUS NERVE AND THE MACHINE WAS RESTARTED, BUT THE SITUATION REMAINED THE SAME. THE DOCTOR DECIDED TO CONTINUE THE PROCEDURE WITHOUT CONTINUOUS MONITORING. NO HEALTH DAMAGE TO THE PATIENT.