BRAVO

Additional Manufacturer Narrative

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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. THE SURGEON WAITED TO DEPLOY UNTIL 30 SECONDS OF UN-IN TERRUPTION BEFORE REMOVING THE WHITE SAFETY CAP AND DEPLOYING THE CAPSULE. THE SURGEON WAS EXPERIENCED AT THIS PROCEDURE AND TOOK THE NECESSARY STEPS TO DEPLOY THE CAPSULE APPROPRIATELY. ONCE THE SURGEON SAW THE WHITE RIBS ON THE DELIVERY DEVICE, IT WAS REMOVED. WHEN CAPSULE PLACEMENT WAS CHECKED, THE CAPSULE WAS FOUND DIRECTLY ABOVE THE VOCAL CORDS. THE SURGEON REMOVED THE FIRST CAPSULE USING FORCEPS. A SECOND CAPSULE WAS PLACED DURING THE SAME PROCEDURE AND ATTACHED SUCCESSFULLY. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.