APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Description of Event or Problem

IT WAS REPORTED THAT DEVICE WAS BEING USED, IT SUDDENLY STOPPED RESPONDING DESPITE NOT TOUCHING THE NERVES. IT IS SAID THAT IT MIGHT BE A CONSUMABLE PRODUCT DEFECT. THE MYOELECTRIC REACTION BECAME ABOUT 8 MICROVOLTS EVEN THOUGH THE NERVE WAS NOT TOUCHED. STIMULATION CURRENT VALUE WAS DISPLAYED. THERE WERE ALERTS WITH REDUCED MYOCARDIUM RESPONSE. PROCEDURE WAS COMPLETED BY USUAL WAY. 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 BIOLOGICAL CONTAMINANTS ON MULTIPLE PORTIONS OF THE DEVICE INCLUDING THE CLIP AND OUTSIDE DIAMETER OF THE WIRE. THE ELECTRODE CONTACT WAS FLUSH WITH THE INSIDE DIAMETER OF THE CLIP BODY AS INTENDED. ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS END TO END AND THE ACTUAL MEASUREMENT WAS 12.1 OHMS WHICH WAS IN SPECIFICATION. IN THE RETURNED CONDITION, THERE WAS NO 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.