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

Model Number FGS-0635

Device Problem Failure to Transmit Record (1521)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

According to the reporter, the recorder stopped connection with the capsule initially when patient was wearing it around the waist.When disconnection was alerted, the patient wore the recorder around the chest and the whole night the recorder kept beeping and there was no real-time ph reading displayed on the screen.Recorder was swapped to eliminate whether the unstable connectivity was due to a faulty recorder.Patient called again and said there was similar beeping with the new recorder despite successful pairing and patient constantly wore it around the chest.Also on the screen, there a was number "1" displayed, however it did not have real time ph reading and there was no blinking indication light.There was no patient and user harm.

Manufacturer Narrative

Concomitant medical products: fgs-0634 (fgs-0634 recorder bravo cf reflux, serial number: (b)(4); fgs-0634 (fgs-0634 recorder bravo cf reflux, serial number: (b)(4).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.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, the electronic device-use logs were available.A review of the system logs showed recorder malfunction was due to a failure in the internal components of the recorder and the ability to pick capsule signal was damaged.Capsule failure was due to it's internal components and the ability of the capsule to function properly was damaged.Ignored during the study, the data was transmitted approximately 2 meters (6 feet).The recorder was shut down.It was reported that the capsule failed to transmit to the recorder during the procedure.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.A secondary review of the device history records found no potentially contributing factors.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: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16131997
• MDR Text Key: 308350713
• Report Number: 9710107-2023-00005
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369707
• UDI-Public: 07290101369707
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2024
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 57259F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2022
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Race: Asian