MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C

Model Number	FGS-0400
Medical Device Problem Codes	Material Fragmentation (1261); Optical Distortion (3000)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the patient underwent the study due to iron deficiency anemia and had no adverse events.The video showed that the capsule entered the esophagus and stomach, and sometime after seven minutes, an irregular white vertical line appeared in the video, transversing the image completely.Then, quickly, the video images became chaotic, but the capsule continued to transmit over 10 hours of video, which made the customer allege the capsule broke inside the body.Upon review of the video by the engineering team, it was determined to be an imager failure of the capsule and not a broken capsule.The patient had an x-ray, and no capsule or capsule parts were visible.The patient did undergo the new capsule study.The patient did not have any adverse symptoms.
Additional Manufacturer Narrative
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: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• 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: 20504712
• Report Number: 9710107-2024-00198
• Device Sequence Number: 15553828
• Product Code: NEZ
• UDI-Device Identifier: 07290101362227
• UDI-Public: 07290101362227
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K211684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: FGS-0400
• Device Catalogue Number: FGS-0400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female