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. 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¿S ESOPHAGUS AND WAS FOUND IN THE ESOPHAGUS. THE CAPSULE WAS RETRIEVED FROM THE PATIENT USING A SNARE. THE PHYSICIAN VERIFIED CAPSULE PLACEMENT ENDOSCOPICALLY. THE DEPLOYMENT DEVICE WAS INSERTED WITH THE CAPSULE FACING THE TONGUE AND THE ENTIRE DEVICE, INCLUDING THE HANDLE, WAS MAINTAINED IN THE HORIZONTAL PLANE. SUCTION WAS APPLIED USING A PUMP, WITH VACUUM PRESSURE REACHING 550 MMHG PRIOR TO PLACEMENT.