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

Model Number	800004-
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that the recorder became hot and started smoking.There were no flames seen.The patient then pulled the catheter out from the nares and removed the recorder from the vicinity and at some point, switched the batteries around so it would not catch on fire while it was transported to the hospital.The screen of the recorder could no longer be seen.The patient's nose and stomach were bleeding.Had one episode of epistaxis in the evening of the test, and had ongoing stomach issues but these were chronic and unrelated to the ph test.A bleeding on the nose occurred prior the procedure or hours before the recorder malfunctioned.The patient applied pressure on the nose and it stopped within 10 minutes.There was likely no bleeding in the stomach.The patient have adhd (attention-deficit/hyperactivity disorder) and had difficulty accurately describing some symptoms and had issues with concentrating on the questions asked.Direct answers to questions were not always provided and other unrelated issues were consistently brought up in the conversation and fixated upon.There was no patient or user harm.
Additional Manufacturer Narrative
D10 concomitant product: 900004, 900004 versaflex-z znis+7r2.0 unkydx10 (lot #: 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.The device was not returned, but the customer provided a c ouple of photos for visual inspection.The photos confirmed that the recorder¿s display was broken and showed visible burn marks on the screen.The rear part of the device was shown both with and without batteries and appeared to be in good condition.Two additional photos of the digitrapper in a disassembled state were also provided.It was reported that the manometry device was smoking and generating excessive heat.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.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: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and photos were available for evaluation.Visual inspection found no abnormalities in the lcd screen, battery case, usb contact, buttons, catheters, or connectors.The lcd screen passed inspection.The battery case showed no cracks or breaks.The usb contact was intact, and all buttons responded when pressed.No visible issues were found with the catheters or connectors.The aa batteries were replaced, and the device powered on without issue.The device successfully connected to the simulator and was calibrated for a test study.No error codes were displayed by the digitrapper.A 1-hour test study was successfully recorded and uploaded into the software.The device accurately recorded the simulated ph levels and patient event markers.No anomalies were noted in the test study.It was reported that the recorder became hot and started smoking.The reported issue 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.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: DIGITRAPPER
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22284186
• Report Number: 9710107-2025-00255
• Device Sequence Number: 18347910
• Product Code: FFT
• UDI-Device Identifier: 07290101362906
• UDI-Public: 07290101362906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: 800004-
• Device Catalogue Number: 800004-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 09/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/31/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown