MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) BRAVO PH IMPLANT; ELECTRODE, PH, STOMACH

Model Number	BRAVO PH MONITOR CAPSULE
Health Effect - Clinical Codes	Chest Pain (1776); Dysphagia/ Odynophagia (1815); Foreign Body In Patient (2687)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Bravo implant stuck in wall of esophagus after 17 days of implanting.Chest pain and trouble swallowing.Need further medical services to remove.Chancing esophagus wall being damaged.Had bravo implant put in october 4.Chest pains and trouble 16 days later.Need to schedule endoscopy to have removed off of esophagus wall chancing tearing of the lining of esophagus.

• Brand Name: BRAVO PH IMPLANT
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18066873
• Report Number: MW5147746
• Device Sequence Number: 7615543
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: BRAVO PH MONITOR CAPSULE
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRAVO IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White