BRAVO

Description of Event or Problem

IT WAS REPORTED THAT TWO CAPSULES FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THE TWO CAPSULES NEVER SEPARATED FROM THE CATHETER; HOWEVER IT DID APPEAR TO PUNCTURE THE TISSUE AS MARKS WERE OBSERVED WHERE THE CUSTOMER ATTEMPTED TO ATTACH THE DEVICE. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. LUBRICATION WAS USED TO FACILITATE THE PLACEMENT OF THE CAPSULE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, G3 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.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: FGS-0635, FGS-0635 CF DELIVERY DEV CAPS BRAVO X5 (LOT#67477F). 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 TWO CAPSULES FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. THE TWO CAPSULES NEVER SEPARATED FROM THE CATHETER; HOWEVER IT DID APPEAR TO PUNCTURE THE TISSUE AS MARKS WERE OBSERVED WHERE THE CUSTOMER ATTEMPTED TO ATTACH THE DEVICE. NO INTERVENTION WAS REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.