BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS AND WAS FOUND RESTING ON THE PATIENT'S TONGUE. THE CAPSULE WAS REMOVED FROM THE PATIENT'S TONGUE WITH FINGERS. THEY PLACED A SECOND CAPSULE ON THE SAME PROCEDURE AND THE CAPSULE DID NOT DETACH FROM THE DELIVERY DEVICE. THE SECOND CAPSULE ONLY DETACHED WHEN THE DEVICE WAS PUT AWAY AFTERWARDS. THE PATIENT EXPERIENCED BLEEDING DURING THE PROCEDURE AND STOPPED AFTER A SHORT TIME FOLLOWING RINSING. LUBRICATION WAS USED DURING CAPSULE PLACEMENT.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT # 68259F). 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.