BRAVO

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE CAPSULE AND DELIVERY SYSTEM WERE RETURNED FOR EVALUATION. THE VISUAL INSPECTION OF THE DELIVERY DEVICE AND CAPSULE FOUND NO NOTABLE CONDITIONS. THE HANDLE WAS RETURNED STUCK IN AN IN-BETWEEN POSITION. THE HANDLE WAS ROTATED THE REST OF THE WAY AND THE DEVICE FUNCTIONED AS EXPECTED, THE CAPSULE DETACHED WITHOUT DIFFICULTY. THE DEVICE PASSED ALL TESTS IN THE LAB, NO FAULTS WERE FOUND. IT WAS REPORTED THAT THE BRAVO CAPSULE FAILED TO DETACH FROM THE DELIVERY SYSTEM DURING USE. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: USING YOUR THUMB, ROTATE THE PLUNGER FROM THE SIDE ONE-EIGHTH (1/8) OF A TURN CLOCKWISE TO RELEASE THE CAPSULE FROM THE DELIVERY DEVICE. THE PLUNGER SPRINGS UP SO THAT A WHITE LINE IS VISIBLE ON THE SIXTH RIB OF THE PLUNGER. 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 REMAINED ATTACHED TO THE DELIVERY SYSTEM UPON REMOVAL. A SECOND CAPSULE WAS PLACED AND IT ATTACHED SUCCESSFULLY. THERE WAS NO PATIENT OR USER HARM. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE. LUBRICANT 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.