BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE DETACHED FROM THE DELIVERY DEVICE BUT PARTIALLY ATTACHED TO ESOPHAGEAL WALL. THE PIN OF THE CAPSULE DID NOT GO ALL THE WAY THROUGH. THE CAPSULE WAS SUBSEQUENTLY LOCATED IN THE ORAL CAVITY. THE CAPSULE WAS RETRIEVED FROM THE PATIENT¿S BODY USING RAPTOR FORCEPS. ANOTHER ATTEMPT WAS MADE TO PLACE A CAPSULE, AND THE SECOND CAPSULE SUCCESSFULLY ATTACHED TO THE ESOPHAGUS. NO LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

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. 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.