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

ACCORDING TO THE PATIENT ALLEGATION, THE BRAVO CAPSULE WAS ATTACHED ON (B)(6) 2026. AFTER A WEEK PROGRESSED, EVERYTHING THE PATIENT ATE FELT LIKE HER BACK WAS RIPPING. ON (B)(6) 2026, THE PATIENT WAS SENT FOR AN X-RAY TO SEE WHERE THE BRAVO CAPSULE WAS BECAUSE THE PATIENT WAS CONTINUING TO HAVE ISSUES. THE X-RAY SHOWED THAT THE CAPSULE WAS STILL ATTACHED, AND BECAUSE THE CAPSULE HAD NOT DETACHED ON ITS OWN AND WAS CAUSING PATIENT PROBLEMS, IT WAS DECIDED THAT THE CAPSULE HAD TO BE REMOVED. ON (B)(6) 2026, THE PATIENT WAS SENT TO (B)(6) HOSPITAL IN (B)(6), WHERE DOCTOR REMOVED IT. DURING THE DOCTOR VISIT, HE STATED THAT HE HAD TO KNOCK ON THE CAPSULE SEVERAL TIMES TO GET IT TO COME LOOSE BECAUSE IT DID NOT WANT TO DETACH. DOCTOR HAD TO PLACE CAPSULE IN THE PATIENTS LOWER STOMACH; WHERE IT WAS NORMALLY SUPPOSED TO BE PLACED AND COULDN'T RISK RETRIEVING FROM THE PATIENT THROAT.