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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING PREPARATION TO DEPLOY THE CAPSULE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SAFETY TAB FROM THE DELIVERY DEVICE HANDLE. WHILE REMOVING THE SAFETY TAB, THE PHYSICIAN BROKE THE PLUNGER OFF THE HANDLE. AS A RESULT, THE DEVICE DID NOT DEPLOY THE CAPSULE AND WAS ABLE TO BE REMOVED FROM THE PATIENT. THE DELIVERY DEVICE WAS THEN SAFELY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT OR USER HARM. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR THE PROCEDURE.