MAUDE Adverse Event Report: MEDTRONIC/GIVEN IMAGING INC. BRAVO ESOPHAGEAL PH TEST CAPSULE; ELECTRODE, PH, STOMACH

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Tissue Damage (2104)

Event Date 09/14/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 i had a 48-hour bravo esophageal ph test capsule placed.Upon waking from procedural sedation, i immediately noticed pain in my chest.I was assured by the surgeon that it was normal.Every time i swallowed, i had pain.I was unable to eat any solid food.My surgeon called to see how i was doing and i told him of my pain.I was told that this can happen in some people.It proceeded to get worse every time i swallowed my own saliva; i was in pain that took my breath away.I spoke to the surgeon again and he ordered an x-ray.I had an x-ray (b)(6) 2018 that showed the bravo still in place.My surgeon decided to schedule me to remove it.On (b)(6) 2018 under general anesthesia, the bravo capsule was removed.Upon waking from this procedure, i was in incredible pain.My surgeon told me that it was hurting because when he removed the capsule, it tore my esophageal wall and he had to place clips to repair it.The pain was absolutely unbearable.I am allergic to several pain medications and i didn't think i could swallow a pill, so i was prescribed liquid tylenol with codeine.I detested how it made me nauseous but it took away the pain.For the next 6 days, all i could do was sleep and drink milkshakes.It was awful.My surgeon called and i did tell him all this, he said it would take time to heal.I was never called for a follow-up appointment.I believe the capsule was placed incorrectly.At the last minute, before the placement procedure, my surgeon had something come up and another surgeon did the procedure.

• Brand Name: BRAVO ESOPHAGEAL PH TEST CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC/GIVEN IMAGING INC.
• MDR Report Key: 8292943
• MDR Text Key: 135155022
• Report Number: MW5083550
• 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: 01/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 64