MAUDE Adverse Event Report: MEDTRONIC / GIVEN IMAGING LTD. BRAVO PH MONITOR; ELECTRODE, PH, STOMACH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Event Description

I had a bravo capsule placed in my esophagus.It created intense chest pain when swallowing, so much so that it was hard to eat.Fda safety report id # (b)(4).

• Brand Name: BRAVO PH MONITOR
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC / GIVEN IMAGING LTD.
• MDR Report Key: 12203502
• MDR Text Key: 262993384
• Report Number: MW5102669
• Device Sequence Number: 1
• Product Code: FFT
• 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: 07/18/2021

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 54