MAUDE Adverse Event Report: MEDTRONIC INC. BRAVO PH RECORDER CAPSULE; ELECTRODE, PH, STOMACH

Patient Problems Chest Pain (1776); Malaise (2359)

Event Date 09/05/2023

Event Type  Injury  

Event Description

I had the bravo ph monitoring capsule placed endoscopically.Immediately upon waking i experienced chest pain.Four days later i am still having chest pain and general malaise, and the doctor who placed it refuses to take it out.

• Brand Name: BRAVO PH RECORDER CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 17745577
• MDR Text Key: 323554463
• Report Number: MW5145627
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White