BRAVO

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#65918F). 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 WAS DEPLOYED BUT FAILED TO ATTACH TO THE ESOPHAGUS AND WAS SUBSEQUENTLY LOCATED IN THE PATIENT¿S MOUTH AFTER DEPLOYMENT. THE CAPSULE WAS RETRIEVED BY HAND FROM THE MOUTH. A SECOND ATTEMPT WAS MADE WITH ANOTHER CAPSULE FROM THE SAME LOT, AND THE SECOND CAPSULE ALSO FAILED TO ATTACH TO THE ESOPHAGUS AND WAS LOCATED IN THE PATIENT¿S MOUTH AFTER DEPLOYMENT; IT WAS ALSO RETRIEVED BY HAND. THE SUCTION PRESSURE WAS REPORTED AS FINE WITH NO SALIVA IN THE SUCTION TUBE, AND THE PIN WAS OBSERVED TO HAVE DEPLOYED WHEN VIEWED THROUGH THE HOLE. THERE WAS NO PATIENT AND USER HARM.