BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0636, FGS-0636 CF DELIVERY DEV CAPS BRAVO X1 (LOT#UNKNOWN); FGS-0636, FGS-0636 CF DELIVERY DEV CAPS BRAVO X1 (LOT#UNKNOWN). 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 THE CAPSULE FAILED TO ATTACH TO THE PATIENT ESOPHAGUS AND FOUND IN THE PATIENT'S STOMACH. THE SECOND ATTEMPT AND THE THIRD ATTEMPT ALSO FAILED. THERE WAS NO PATIENT OR USER HARM.