BRAVO

Description of Event or Problem

IT WAS REPORTED THAT THE CAPSULE FAILED TO DEPLOY AND DID NOT DISCONNECT FROM THE DELIVERY DEVICE. THE PATIENT HAD A SMALL SUPERFICIAL TEAR ON THE MUCOUS MEMBRANE AND HAD SOME DIFFICULTY SWALLOWING FOR ABOUT 24 HOURS. TWO 40MG OF PROTON PUMP INHIBITORS WERE ADMINISTERED TO ADDRESS RETROSTERNAL DISCOMFORT AND PROTECT AGAINST SMALL LESIONS AFTER THE CAPSULE HAD TO BE PULLED AWAY. LUBRICATION WAS USED TO FACILITATE CAPSULE PLACEMENT.

Additional Manufacturer Narrative

H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED MULTIPLE IMAGES OF THE DEVICE PACKAGING; THE LOT NUMBER OF THE DEVICE WAS CONFIRMED. AN UNRELATED IMAGE OF MANOMETRY EQUIPMENT WAS ALSO NOTED. A COMPREHENSIVE EXAMINATION COULD NOT BE PERFORMED, BECAUSE THE RETURNED SAMPLE WAS NOT RECEIVED IN A STATE THAT ALLOWED FULL FUNCTIONAL OR VISUAL ASSESSMENT. IT WAS REPORTED THAT THE CAPSULE FAILED TO DETACH FROM THE DELIVERY SYSTEM DURING USE. 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.