APS (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ON FOLLOW-UP, ADDITIONAL INFORMATION FROM THE REP REPORTED THAT THE CUSTOMER BELIEVES THAT THE ELECTRODE FELL OUT. AT THE POINT WHERE THE ELECTRODE DID NOT STIMULATE ANYMORE, THE SILICONE RING WAS VISUALLY CHECKED AND NORMALLY THE ELECTRODE IS VISIBLE AS A SMALL METAL POINT. IN THIS CASE, THERE SEEMED TO BE A SMALL HOLE INDICATING THAT THERE WAS NO ELECTRODE AT THE SURFACE. THIS LOGICALLY EXPLAINED TO THE CUSTOMER THAT THE ELECTRODE STOPPED WORKING.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT HAPPENED SEVERAL TIMES WITH 2MM AND 3MM ELECTRODES. IT WAS NOTED THAT THEY DON'T KNOW THE DATES OF THE EVENTS AND NOT SURE WHEN IT WAS 2MM OR 3MM ELECTRODES. THEY NEVER KEPT THE ELECTRODES IN QUESTION. INITIALLY, THE ELECTRODE WORKS WELL. BUT AFTER ONE TIME OR SEVERAL TIME THAT THE ELECTRODE WAS DETACHED BY MISTAKE FROM THE NERVE, THE ELECTRODE WAS NOT STIMULATING ANYMORE. WHEN LOOKING IN DETAIL AT THE ELECTRODE, THE SURGEON COULD SEE THAT THERE WAS A SMALL HOLE INSTEAD OF THE ELECTRODE THAT WE USUALLY SEE INSIDE THE CUFF. ONLY ONCE, THE ELECTRODE HAD THIS ISSUE FROM THE BEGINNING OF THE SURGERY. ON FOLLOW-UP, IT WAS REPORTED THAT EVENT DIDN¿T IMPACT THE PATIENTS AS THEY JUST CHANGED THE ELECTRODES WITH NEW ONES AND IT WORKED PERFECTLY. IT WAS ALSO REPORTED THAT NOTHING WAS CAUSING A LACK OF RESPONSE.