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

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problems Tissue Breakdown (2681); Foreign Body In Patient (2687)

Event Date 05/01/2017

Event Type  Injury  

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.

Event Description

According to the reporter, the capsule has been placed for diagnostics purposes on (b)(6) 2017 but it was stuck inside the patient until (b)(6) 2022.A surgeon removed the capsule at 50cm damaged to the intestines.The patient noted to have a chron's disease, an inflammation before swallowing the capsule.This also had caused patient unable to eat at times.

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 a photo was available for evaluation.Visual inspection noted that the picture showed a disassembled capsule outside of the patient¿s body.Functional testing found that the capsule has been placed for diagnostics purposes on (b)(6) 2017 but it was stuck inside the patient until (b)(6) 2022.The patient noted to have a chron's disease, an inflammation before swallowing the capsule.The incident was 7 years ago and was never reported.2 year ago the patient had a surgeon removed the capsule at 50cm damaged to the intestines.According to the screenshots submitted from a social media website, after 5 years the capsule was cracked.A functional evaluation could not be completed.Although retained pillcam capsules have remained intact for many years, the capsule is not designed to remain intact for so many years in the bowel.Most likely that the capsule retention was related to the patient medical history.Is not mention if the patient performed patency capsule test before or no.The pillcam patency capsule is an ingestible and dissolvable capsule, similar in size to the pillcam capsules and is intended to verify the patency of the gastrointestinal tract.Attempts to contact the facility and physicians reported were unsuccessful in obtaining information on this event.It was reported that the pillcam capsule was retained.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: causes of retention cited in the literature include: nsaid strictures, crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis.Summaries in published literature identify the overall risk of retention for capsule endoscopy to be 1.4%.The risk of retention for obscure bleeding is estimated to be 1.2%, for suspected crohn's disease to be 2.6%, for known crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is (b)(4) as compared to healthy volunteers [1].To verify passage of the capsule from the gi tract, an abdominal x-ray may be obtained at the discretion of the physician.The capsule can be removed using medical, endoscopic or surgical intervention.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: UNKNOWN PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• 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: 19003685
• MDR Text Key: 338904419
• Report Number: 9710107-2024-00053
• Device Sequence Number: 1
• Product Code: NEZ
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female