BRAVO

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.

Description of Event or Problem

IT WAS REPORTED THAT WHEN THE DEVICE WAS OPENED FROM THE PACKAGING, THE PROTECTIVE PIECE ON THE PLUNGER WAS MISSING. DURING THE PROCEDURE, THE CAPSULE DID NOT DEPLOY FROM THE CATHETER. THE CAPSULE ATTACHED TO THE ESOPHAGUS BUT FAILED TO DETACH FROM THE DELIVERY DEVICE. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE. THERE WAS NO PATIENT OR USER HARM.