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 A PATIENT CAPSULE MONITORING FOR INVESTIGATION OF UPPER GASTROINTESTINAL SYMPTOMS AND SUBSEQUENTLY EXPERIENCED A POSSIBLE HYPERSENSITIVITY-TYPE REACTION. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED FACIAL RASH, FACIAL ERYTHEMA/REDNESS, MILD FACIAL SWELLING, PALPITATIONS, DIZZINESS, AND GENERALIZED WEAKNESS. THE PATIENT CONTACTED THE HEALTHCARE PROVIDER AND WAS ASSESSED IN CLINIC BY A PHYSICIAN WITH INPUT FROM AN ENDOSCOPY CONSULTANT, AND THE ASSESSMENT NOTED FACIAL RASH AND ERYTHEMA WITH NO AIRWAY COMPROMISE AND NO CLINICAL FEATURES OF ANAPHYLAXIS. ANTIHISTAMINES AND CORTICOSTEROIDS WERE ADMINISTERED, AND THE PATIENT WAS OBSERVED AFTER ADMINISTRATION; SYMPTOMS IMPROVED PRIOR TO DISCHARGE AND SUBSEQUENTLY RESOLVED OVER THE FOLLOWING DAYS WITHOUT LASTING HARM. GIVEN THE TEMPORAL ASSOCIATION WITH CAPSULE PLACEMENT AND THE PRESENCE OF METAL COMPONENTS INCLUDING NICKEL, A POSSIBLE DEVICE-R ELATED HYPERSENSITIVITY REACTION WAS CONSIDERED, ALTHOUGH CAUSATION COULD NOT BE DEFINITIVELY ESTABLISHED.