MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN BRAVO; ELECTRODE, PH, STOMACH

Model Number UNKNOWN BRAVO

Device Problem Entrapment of Device (1212)

Patient Problems Asthma (1726); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Vomiting (2144); Respiratory Tract Infection (2420); Nasal Obstruction (2466); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient experienced severe chest pains, dysphagia, runny nose, difficulty breathing, and vomiting large amounts of stomach secretions a few days after the capsule was placed.The capsule was placed on (b)(6) 2019.The patient was seen by an ent (ears, nose and throat), a family physician, and a respiratory specialist.The patient was diagnosed of having asthmatic attacks exacerbation.The patient went on a trip and the respiratory issues became more severe.On (b)(6) 2019, the patient was seen on an urgent care center and was diagnosed with purulent bronchitis, moderate asthma (exacerbation), chronic fatigue, and shortness of breath.A spirometer was used to check expiratory flow rate and the patient was sent to an outpatient laboratory to have a chest x-ray.The x-ray revealed that there was foreign body on the patient's chest wall.The physician was able to review the chart details.The patient had functional dyspepsia with delayed gastric emptying and at some point placement of a gastric stimulator device was considered.On the chart, it was verified that the procedure was performed (b)(6) 2019.The physician stated that the procedure went smoothly without any unusual event.The study results showed significant acid reflux with a strong symptom correlation.The patient w as 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 study, a chest x ray was performed that reportedly shown no foreign body.Recurrent respiratory problems were felt to be completely unrelated to the procedure.The patient subsequently had another chest x-ray later than month that did show the retained bravo capsule in the esophagus.The patient was referred back to the physician and they performed an elective upper endoscopy and removed the capsule with a snare uneventfully.The physician found much less mucosal irritation that they had expected to find at the time.No significant ulceration was present.The patient was then referred for elective anti-reflux surgery.The breathing issues described in the complaint were not believed to be related to the procedure or the retained capsule.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.The primary analysis noted that there was a patient device interaction issue.It was reported that the capsule remained in the patient longer than expected and there was incomplete or delayed procedure with medical intervention.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: discomfort associated with the capsule, or failure to detach from the esophagus within several days after placement, either of which may necessitate endoscopic removal.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10792269
• MDR Text Key: 214790332
• Report Number: 9710107-2020-00609
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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
• Device Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention