MAUDE Adverse Event Report: GIVEN IMAGING INC. MEDTRONIC BRAVO REFLEX CAPSULES PH; ELECTRODE, PH, STOMACH

Device Problem Entrapment of Device (1212)

Patient Problems Asthma (1726); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Vomiting (2144); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/29/2019

Event Type  No Answer Provided  

Event Description

(b)(6) received (b)(4) from (b)(6) from a complainant who resides in (b)(6), who stated that subject capsule inserted into her esophagus was defective caused her numerous medical symptoms (respiratory, severe chest pain, dysphagia, runny nose, vomiting large amounts of stomach secretions and was diagnosed as having asthmatic attacks exacerbation.I was finally able to reach dr.(b)(6) at (b)(6) health care in (b)(6), by phone earlier today.He is a gi motility expert and experienced bravo user.He performs the procedure about 2-3 times per month for over ten years.The patient in the fda complaint has been well known to him and he recalls the particulars of the events that transpired last year.He also was able to review chart details.He was surprised to learn that a complaint to the fda had been filed.The patient had functional dyspepsia with delayed gastric emptying and at some point placement of a gastric stimulator device was considered.In her evaluation, a bravo procedure was performed on (b)(6) 2019.He states that the procedure went smoothly without any unusual event.The study results showed significant acid reflux with a strong symptom correlation.The patient was known to have recurrent respiratory problems and was followed for several years by the pulmonary department at the hospital dating from at least 2016 if not earlier.At a visit with the pulmonologist in (b)(6) 2019, over a month after the bravo study, a chest x ray was performed that reportedly shown no foreign body.In hindsight, dr (b)(6) believes that a retained bravo capsule in the esophagus was missed in the report.Recurrent respiratory problems were felt to be completely unrelated to the bravo procedure.The patient subsequently had another chest x ray later than month that did show the retained bravo capsule in the esophagus.She was referred back to dr.(b)(6) and he performed an elective upper endoscopy and removed the bravo capsule with a snare uneventfully.He recalls that he was surprised to find much less mucosal irritation that he had expected to find at the time.He believes the patient suffered no adverse effects from having had the retained capsule.No significant ulceration was present.The patient was then referred for elective anti-reflux surgery.Overall, dr.(b)(6) is quite pleased with the bravo capsule procedure.I was fortunate to be able to set up a short phone call with him between endoscopic procedures and i believe the information gathered is sufficient to complete our assessment.In brief, it appears that this case represents a common circumstance where the capsule was retained and it was remove endoscopically.The breathing issues described in the complaint are not believed to be related to the bravo procedure or the retained capsule.

• Brand Name: MEDTRONIC BRAVO REFLEX CAPSULES PH
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 12664887
• MDR Text Key: 278349546
• Report Number: MW5104761
• Device Sequence Number: 1
• Product Code: FFT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1