BRAVO

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE CAPSULE AND DELIVERY SYSTEM WERE RETURNED FOR EVALUATION. PHOTOS WERE ALSO PROVIDED. VISUAL INSPECTION OF THE HANDLE AND CAPSULE FOUND NO NOTABLE CONDITIONS. THE FOAM GASKET WAS MISPLACED AND WAS INTERFERING WITH THE ACTIVATION OF THE DEVICE. IT WAS REPORTED THAT THE CAPSULE FAILED TO ATTACH TO THE PATIENT'S ESOPHAGUS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 PATIENT¿S STOMACH. THE CAPSULE WAS RETRIEVED USING A ROTH NET. A SECOND CAPSULE WAS PLACED AND ATTACHED SUCCESSFULLY. NO LUBRICANT WAS USED TO FACILITATE CAPSULE PLACEMENT.