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 THE CAPSULE WAS SUCCESSFULLY PLACED IN THE PATIENT ESOPHAGUS, WITH PLACEMENT VERIFIED BY VISUALIZATION AND PICTURES. WHEN ATTEMPTING TO PAIR THE RECEIVER TO THE CAPSULE, THE RECEIVER DID NOT PAIR. OTHER RECORDERS WERE TRIED, HOWEVER NONE OF THEM PAIRED WITH THE CAPSULE, WHICH HAD ALREADY BEEN PLACED. THERE WAS NO PATIENT AND USER HARM, AND NO INTERVENTION WAS REQUIRED.