BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE FAILED TO DETACH FROM THE DELIVERY DEVICE. IT FELL IN THE MOUTH WHEN PULLING OUT. A SECOND ATTEMPT TO PLACE THE CAPSULE WAS PERFORMED AND IT ALSO FAILED. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE. THERE WAS NO PATIENT OR USER HARM.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#67843F) 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.