MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) BRAVO CF PH CAPSULE DELIVERY SYSTEM; ELECTRODE, PH, STOMACH

Model Number	FGS-0635100
Health Effect - Clinical Codes	Chest Pain (1776); Dysphagia/ Odynophagia (1815); Distress (2329); Laceration(s) of Esophagus (2398)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The bravo capsule was placed via egd (esophagogastroduodenoscopy) on (b)(6) in the morning.In recovery, the patient experienced immediate discomfort but was told it would get better.The pain continued to worsen.The patient was unable to eat or drink anything substantial due to the pain.The patient went to the emergency room at 10:30 pm on (b)(6).The patient was having difficulty swallowing their own spit and was having sharp chest/sternum pain that seemed to be similar to contractions in their esophagus.The hospital called the doctor and he indicated that he would have to remove it but not until the next day.The patient was admitted to the hospital and kept npo for surgery.The removal surgery did not occur until (b)(6) at around 2:30 pm.The doctor told the patient that the device appeared to cause the "sloughing off of the entire esophagus" but does not know why.The patient lost 2 days of work, planned social activities and suffered incredible pain.The patient was not informed of previous issues with this product or the fact that there had just been a recall.The patient's concerns were dismissed by the physician.Medtronic does not even have a customer support phone number for this product.When called, the staff at medtronic stated that it is "up to hospital, doctor and sales/marketing staff to report adverse effects".

• Brand Name: BRAVO CF PH CAPSULE DELIVERY SYSTEM
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 22719758
• Report Number: MW5174055
• Device Sequence Number: 8657531
• Product Code: FFT
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-0635100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White