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 Chest Pain (1776); Dysphagia/ Odynophagia (1815); Vomiting (2144); Unintended Radiation Exposure (4565)

Event Date 06/29/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, a procedure was performed with a defective capsule that was inserted into the patient's esophagus which caused numerous medical symptoms like severe chest pain, dysphagia, runny nose, vomiting large amounts of stomach secretions and was diagnosed as having asthma attack with exacerbation.The patient had functional dyspepsia with delayed gastric emptying and at some point placement of a gastric stimulator device was considered.The physician stated 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.A month after the procedure, a chest x-ray was performed that reportedly showed no foreign body.Recurrent respiratory problems were completely unrelated to the procedure.The patient had another chest x-ray after a month that did show the retained capsule in the esophagus.The doctor performed an elective upper endoscopy and removed the capsule with a snare uneventfully.There was less mucosal irritation than expected.The patient suffered no adverse effects from having the capsule retained.No significant ulceration was present.

Manufacturer Narrative

Additional information: g1 (first name, last name, email, phone number), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.It was reported that the capsule remained in the patient longer than expected.The reported issue was 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.The instructions included with this device provide the following guidance: potential complications include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, hypertension, respiratory arrest, and cardiac arrhythmia or arrest.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.

• Brand Name: UNKNOWN BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: clay chandler ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 3035306409
• MDR Report Key: 12910691
• MDR Text Key: 281530832
• Report Number: 9710107-2021-00487
• 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: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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 Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/03/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention