APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE

Additional Manufacturer Narrative

CORRECTION IN G4: ¿PMA / 510(K) # NUMBER WAS NOT PROVIDED IN PREVIOUS REPORT. 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 ESOPHAGEAL CANCER SURGERY, AN ATTEMPT TO OBTAIN A BASELINE USING AN APS ELECTRODE FAILED TO DELIVER STIMULATION, LEADING TO THE USE OF A SPARE PRODUCT, WHICH FUNCTIONED NORMALLY, SUGGESTING A DEFECT IN THE ORIGINAL PRODUCT. THE MOVEMENT NEAR THE STIMULATION SITE, IMPLYING THAT STIMULATION MIGHT HAVE BEEN CONVEYED DESPITE THE ABSENCE OF A 'STIMULUS DELIVERY' TONE AND NO WAVEFORM DISPLAY ON THE MONITOR. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT VISUALLY, THE PRODUCT WAS RETURNED IN A SMALL ZIP LOCK BAG. THERE WAS A BIOLOGICAL CONTAMINATION ON THE C-CLIP. THE C-CLIP CONTACT WAS PULLED INTO THE CLIP BODY, AND IT DOES NOT FLUSH WHEN C-CLIP IS OPEN. THE STIMULATION POINT WAS NOT ALIGNED WITH C-CLIP BODY. THE MISALIGNMENT OF A STIMULATION POINT (CONTACT) COULD RESULT IN IMPROPER ELECTRODE FUNCTION. 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 11.8 OHMS. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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.