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 WERE SIGNS OF BIOLOGICAL CONTAMINATION ON THE C-CLIP. THE STIMULATION POINT WAS NOT FLUSH TO THE DISTAL END OF THE C-CLIP AND NOT ALIGNED WITH THE CLIP BODY. ELECTRICALLY, THE RESISTANCE SHALL BE LESS THAN 25 OHMS AND ACTUAL MEASUREMENT WAS 12.7 OHMS WHICH IS WITHIN SPECIFICATION. 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 PRIOR TO USE, APS ELECTRODE WAS PLACED, AND AN ATTEMPT WAS MADE TO OBTAIN THE BASELINE, BUT THERE WAS NO RESPONSE. THE DEVICE COULD BE USED WITHOUT ISSUES WHEN IT WAS REPLACED WITH A NEW ONE. AN APS ELECTRODE DEFECT WAS SUSPECTED IN THE SITUATION. NOT ASSOCIATED WITH THE PATIENT.