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

Model Number	UNKNOWN BRAVO
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, in the first part of the study, the recorder made a sound and the red light turned on.While on the second part of the study, there was no connection with the capsule however no particular alarms have occurred.There was no patient or user harm.
Additional Manufacturer Narrative
D10 concomitant product: unk-bravo, unknown bravo, (lot number: unknown) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.A log files patient study and images of the study were ava ilable for evaluation.A photo provided by the customer showed that there were several gaps in data during the bravo study.After reviewing the graphs, it was confirmed that the bravo recorder captured data for 96 hours and 27 minutes.The graphs also showed that the capsule continued to transmit until the end of the study.However, several gaps in the signal were observed throughout.These gaps may have been caused by the patient being too far from the recorder.It was reported that the capsule failed to transmit to the recorder during the procedure.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: instruct the patient to make sure that the recorder is always monitoring the capsule.The patient must stay within 2 meters of the recorder during the study except, as necessary, for bathing.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BRAVO
• Common Device Name: 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22478692
• Report Number: 9710107-2025-00293
• Device Sequence Number: 15439543
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE COMMENT ON H11.
• Patient Sex: Unknown