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

Model Number UNKNOWN BRAVO

Device Problem Entrapment of Device (1212)

Patient Problems Vomiting (2144); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Title: esophageal ph capsule retention source: acg case reports journal / volume 7, 2020 june 23.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed 2019-2020, the capsule was found to be lodged on distal esophagus 45 days after the initial placement.The patient had a significant medical history including spastic quadriplegic cerebral palsy, global developmental delay, seizure disorder, gastrostomy tube dependence, and severe erosive gerd.The patient presented for treatment after multiple episodes of coffee ground emesis (vomiting) for 2 days.Laboratory abnormalities included a hemoglobin count of 6.3 g/dl.An abdominal x-ray revealed the retained capsule and it required an upper endoscopy for evaluation of coffee ground emesis and capsule removal.An irregularly pale esophagus with no active bleeding was visualized with fibrosis alternating with reactive hyperplastic tissue growth noted in the mid to distal esophagus.Significant hyperplastic tissue growth was noted along the region where the capsule was lodged, which likely contributed to capsule retention.The tissue grew around the capsule, acted as a nest and partially entombing the retained capsule.The patient¿s underlying gerd and erosive esophagitis may have also stimulated excess tissue development, preventing the spontaneous dislodgement of the capsule.The capsule was removed via a cold snare without complications, and the patient was discharged 3 days later.

Manufacturer Narrative

Additional information: g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.A picture and literature data were analyzed.Review of the data found there was a patient-device interaction issue.It was reported that the capsule remained in the patient longer than expected.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: potential complications include, but are not limited to: discomfort associated with the capsule, or failure to detach from the esophagus within several days after placement, either of which may necessitate endoscopic removal.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: UNKNOWN BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10339219
• MDR Text Key: 200827505
• Report Number: 9710107-2020-00324
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN BRAVO
• Device Catalogue Number: UNKNOWN BRAVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR