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 COULD NOT BE PROPERLY DETACHED AND FAILED TO ATTACH TO THE ESOPHAGUS, REMAINING ATTACHED TO THE DELIVERY DEVICE. A SECOND ATTEMPT TO PLACE A CAPSULE WAS PERFORMED AND THE CAPSULE WAS SUCCESSFULLY ATTACHED. MEDELA SUCTION WAS USED DURING PLACEMENT. THERE WAS NO PATIENT OR USER HARM.