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

Model Number BRAVO PH MONITOR CAPSULE

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Foreign Body In Patient (2687)

Event Date 10/19/2023

Event Type  Injury  

Event 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
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18066873
• MDR Text Key: 327407599
• Report Number: MW5147746
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361695
• UDI-Public: 07290101361695
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: BRAVO PH MONITOR CAPSULE
• Patient Sequence Number: 1
• Treatment: BRAVO IMPLANT.
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White